Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis (CENTAUR)

• ClinicalTrials.gov Identifier: NCT02217475
• Recruitment Status: Completed
• First Posted: August 15, 2014
• Results First Posted: May 10, 2019
• Last Update Posted: May 10, 2019
• Sponsor: Tobira Therapeutics, Inc.
• Information provided by (Responsible Party): Tobira Therapeutics, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Nonalcoholic Steatohepatitis
• Interventions: Drug: Cenicriviroc; Drug: Placebo
• Enrollment: 289

Participant Flow

Recruitment Details
Pre-assignment Details	In total, 812 participants were screened, and 289 participants were randomized to treatment period 1. Of the 289 participants randomized, 250 participants completed Treatment Period 1. A total of 242 participants entered Treatment Period 2 and 212 completed.

Arm/Group Title	Placebo/Placebo	Placebo/Cenicriviroc (CVC) 150 mg	CVC 150mg/CVC 150 mg
Arm/Group Description	Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.	Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.	CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.
Period Title: Treatment Period 1 (Year 1)
Started	72	72	145
Safety Analysis Set [1]	72	72	144
Completed	62	64	124
Not Completed	10	8	21
Reason Not Completed
Protocol Deviation (with non-compliance)	0	1	0
Adverse Event	4	5	9
Lost to Follow-up	1	0	0
Subject Withdrew Consent	5	2	11
Other Miscellaneous Reasons	0	0	1
[1] Received at least one dose of study drug.
Period Title: Discontinued After Period 1
Started	62	64	124
Completed	60	61	121
Not Completed	2	3	3
Reason Not Completed
Adverse Event	1	2	0
Participant Withdrew Consent	1	1	2
Physician Decision	0	0	1
Period Title: Treatment Period 2 (Year 2)
Started	60	61	121
Completed	58	59	109
Not Completed	2	2	12
Reason Not Completed
Adverse Event	0	1	5
Lost to Follow-up	0	1	2
Subject Withdrew Consent	2	0	2
Physician Decision	0	0	2
Other Miscellaneous Reasons	0	0	1

Baseline Characteristics

Arm/Group Title		CVC 150mg/CVC 150 mg	Placebo/Cenicriviroc (CVC) 150 mg	Placebo/Placebo	Total
Arm/Group Description		CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.	Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.	Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.	Total of all reporting groups
Overall Number of Baseline Participants		145	72	72	289
Baseline Analysis Population Description		Intent-to-treat (ITT) population included all randomized participants regardless of starting treatment.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	145 participants	72 participants	72 participants	289 participants
		54.6 (10.22)	55.3 (10.38)	52.1 (11.37)	54.1 (10.59)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	145 participants	72 participants	72 participants	289 participants
	Female	73 50.3%	39 54.2%	40 55.6%	152 52.6%
	Male	72 49.7%	33 45.8%	32 44.4%	137 47.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	145 participants	72 participants	72 participants	289 participants
Hispanic or Latino		23 15.9%	18 25.0%	7 9.7%	48 16.6%
Not Hispanic or Latino		122 84.1%	51 70.8%	65 90.3%	238 82.4%
Not reported		0 0.0%	2 2.8%	0 0.0%	2 0.7%
Unknown		0 0.0%	1 1.4%	0 0.0%	1 0.3%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	145 participants	72 participants	72 participants	289 participants
Asian		6 4.1%	6 8.3%	9 12.5%	21 7.3%
American Indian or Alaska Native		0 0.0%	0 0.0%	1 1.4%	1 0.3%
Black or African American		5 3.4%	1 1.4%	2 2.8%	8 2.8%
Native Hawaiian or Other Pacific Islander		3 2.1%	0 0.0%	0 0.0%	3 1.0%
White		129 89.0%	63 87.5%	58 80.6%	250 86.5%
Other		2 1.4%	2 2.8%	2 2.8%	6 2.1%

Outcome Measures

1. Primary Outcome

Title	Number of Participant With Hepatic Histological Improvement in NAS by ≥ 2 Points With at Least 1-Point Reduction in Either Lobular Inflammation or Hepatocellular Ballooning and no Concurrent Worsening of Fibrosis at Year 1
Description	Hepatic histological improvement in Nonalcoholic Fatty Liver Disease Activity Score (NAS) at Year 1 was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Evaluation of fibrosis stage was based on the nonalcoholic steatohepatitis clinical research network (NASH CRN) fibrosis staging system, which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. Worsening of fibrosis stage was defined as progression of NASH CRN fibrosis stage.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants regardless of starting treatment.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	144	145
Measure Type: Count of Participants; Unit of Measure: Participants
	27 18.8%	23 15.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CVC 150 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5194
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.816
	Confidence Interval	(2-Sided) 95%; 0.439 to 1.516
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1
Description	Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants regardless of starting treatment.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	144	145
Measure Type: Count of Participants; Unit of Measure: Participants
	4 2.8%	7 4.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CVC 150 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0388
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.934
	Confidence Interval	(2-Sided) 95%; 1.035 to 3.614
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage and Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2
Description	Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

ITT population Year 2 included all participants who had an evaluable year 1 biopsy and received at least 1 dose of study drug during Year 2.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	57	178
Measure Type: Count of Participants; Unit of Measure: Participants
	2 3.5%	5 2.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CVC 150 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5920
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.249
	Confidence Interval	(2-Sided) 95%; 0.553 to 2.821
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 1
Description	Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants regardless of starting treatment.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	144	145
Measure Type: Count of Participants; Unit of Measure: Participants
	8 5.6%	11 7.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CVC 150 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4941
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.396
	Confidence Interval	(2-Sided) 95%; 0.537 to 3.628
	Estimation Comments	[Not Specified]

5. Secondary Outcome

Title	Number of Participants With Complete Resolution of Steatohepatitis With no Concurrent Worsening of Fibrosis Stage at Year 2
Description	Complete resolution of steatohepatitis was defined as histopathologic interpretation of no fatty liver disease, or simple or isolated steatosis with no steatohepatitis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN fibrosis staging system which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

ITT population Year 2 included all participants who had an evaluable year 1 biopsy and received at least 1 dose of study drug during Year 2.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	57	178
Measure Type: Count of Participants; Unit of Measure: Participants
	3 5.3%	11 6.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CVC 150 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8434
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.142
	Confidence Interval	(2-Sided) 95%; 0.305 to 4.277
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 1
Description	The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants regardless of starting treatment.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	144	145
Measure Type: Count of Participants; Unit of Measure: Participants
	15 10.4%	29 20.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CVC 150 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0234
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.201
	Confidence Interval	(2-Sided) 95%; 1.113 to 4.352
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Number of Participants With Improvement in Fibrosis by at Least 1 Stage (NASH CRN System) and no Worsening of Steatohepatitis at Year 2
Description	The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 stages where, 0=None to 4=Cirrhosis. As per NASH CRN system, no worsening of steatohepatitis was defined as no worsening of lobular inflammation or hepatocellular ballooning grade.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

ITT analysis set Year 2 included all participants who have an evaluable year 1 biopsy and who received at least one dose of study drug during Year 2 (after the 1 year biopsy).

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	57	178
Measure Type: Count of Participants; Unit of Measure: Participants
	8 14.0%	27 15.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, CVC 150 mg
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7474
	Comments	[Not Specified]
	Method	Regression, Logistic
	Comments	Logistic regression model was used for analysis. Randomized treatment group, NAS score at screening and fibrosis stage were the factors.
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.154
	Confidence Interval	(2-Sided) 95%; 0.484 to 2.752
	Estimation Comments	[Not Specified]

8. Secondary Outcome

Title	Number of Participants With Deaths, Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs Leading Study Drug to Discontinuation
Description	A TEAE was defined as any adverse event that started or worsened on or after the start of the study medication and up to 30 days after the discontinuation of the study medication. An SAE was defined as any untoward medical occurrence that, at any dose, results in death, was life threatening, requires hospitalization or results in prolongation of existing hospitalization, results in disability/incapacity, or was a congenital anomaly/birth defect.
Time Frame	Years 1 and 2

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.

Arm/Group Title	CVC 150 mg/CVC 150 mg	Placebo/CVC 150 mg	Placebo/Placebo
Arm/Group Description:	CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.	Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.	Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
Overall Number of Participants Analyzed	144	72	72
Measure Type: Count of Participants; Unit of Measure: Participants
Deaths	0 0.0%	0 0.0%	0 0.0%
TEAEs	137 95.1%	68 94.4%	70 97.2%
SAEs	25 17.4%	8 11.1%	12 16.7%
TEAEs Leading Study Drug to Discontinuation	14 9.7%	8 11.1%	5 6.9%

9. Secondary Outcome

Title	Number of Participants With Clinically Significant Changes in Vital Signs
Description	Vital signs included blood pressure, temperature, heart rate, and respiration rate. Vital signs were reviewed by the Investigator for clinically significant changes.
Time Frame	Years 1 and 2

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.

Arm/Group Title	CVC 150 mg/CVC 150 mg	Placebo/CVC 150 mg	Placebo/Placebo
Arm/Group Description:	CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.	Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.	Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
Overall Number of Participants Analyzed	144	72	72
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%

10. Secondary Outcome

Title	Number of Participants With Clinical Laboratory Abnormalities
Description	Grade 3-4 abnormal clinical laboratory values that occurred in ≥2% participants were reported. Criteria used for various parameters was:Fasting glucose Grade3:>250 - 500 mg/dL and Grade4: >500 mg/dL; Alanine aminotransferase(ALT)Grade3:>5.0 - 20.0 ×Upper Limit of Normal(ULN)and Grade4:>20.0 ×ULN; Aspartate aminotransferase(AST)Grade3: >5.0 - 20.0 ×ULN and Grade4: >20.0 ×ULN; Activated partial thromboplastin(APT)/Partial thromboplastin time(PTT)Grade3: >2.5×ULN; Triglycerides Grade3 >500 - 1000 mg/dL and Grade4: >1000 mg/dL; Gamma-glutamyl transferase(GGT)Grade3: >5.0 - 20.0 ×ULN and Grade4: >20.0 ×ULN; Creatine kinase Grade 3: >5.0 - 10.0 ×ULN and Grade4: >10.0 ×ULN; Uric acid Grade3:(ULN - 10 mg/dL; ULN - 0.59 mmol/L) and Grade4: >10 mg/dL; Amylase Grade3: >2.0 - 5.0 ×ULN and Grade4: >5.0 ×ULN; Lipase Grade3: >2.0 - 5.0 xULN and Grade4: >5.0 xULN; Phosphorus Grade3: <2.0 - 1.0 mg/dL and Grade4: <1.0 mg/dL and Absolute neutrophil Grade3: <1.0 - 0.5 × 109/L and Grade4: <0.5 × 109/L.
Time Frame	Years 1 and 2

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.

Arm/Group Title	CVC 150 mg (Year 1)	Placebo (Year 1)	CVC 150 mg	Placebo Then CVC 150 mg	Placebo Then Placebo
Arm/Group Description:	CVC 150 mg tablet, once daily in the morning with food in Year 1.	Placebo-matching cenicriviroc tablet once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2. Includes AEs that occurred in Year 2.	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2. Includes AEs that occurred in Year 2.
Overall Number of Participants Analyzed	144	144	121	61	60
Measure Type: Count of Participants; Unit of Measure: Participants
Fasting glucose (Grade 3)	17 11.8%	13 9.0%	10 8.3%	6 9.8%	5 8.3%
Fasting glucose (Grade 4)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
ALT (Grade 3)	17 11.8%	17 11.8%	4 3.3%	3 4.9%	2 3.3%
ALT (Grade 4)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
AST (Grade 3)	7 4.9%	10 6.9%	1 0.8%	3 4.9%	1 1.7%
AST (Grade 4)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
APT/PTT (Grade 3)	4 2.8%	2 1.4%	1 0.8%	1 1.6%	2 3.3%
Triglycerides (Grade 3)	5 3.5%	7 4.9%	6 5.0%	5 8.2%	2 3.3%
Triglycerides (Grade 4)	3 2.1%	3 2.1%	2 1.7%	0 0.0%	1 1.7%
GGT (Grade 3)	8 5.6%	7 4.9%	8 6.6%	2 3.3%	2 3.3%
GGT (Grade 4)	1 0.7%	1 0.7%	1 0.8%	0 0.0%	0 0.0%
Creatine kinase (Grade 3)	6 4.2%	7 4.9%	1 0.8%	2 3.3%	4 6.7%
Creatine kinase (Grade 4)	2 1.4%	2 1.4%	3 2.5%	1 1.6%	0 0.0%
Uric acid (Grade 3)	9 6.3%	8 5.6%	4 3.3%	3 4.9%	2 3.3%
Uric acid (Grade 4)	11 7.6%	6 4.2%	5 4.1%	1 1.6%	6 10.0%
Amylase (Grade 3)	6 4.2%	1 0.7%	4 3.3%	0 0.0%	1 1.7%
Amylase (Grade 4)	3 2.1%	0 0.0%	2 1.7%	0 0.0%	0 0.0%
Lipase (Grade 3)	4 2.8%	2 1.4%	3 2.5%	0 0.0%	1 1.7%
Lipase (Grade 4)	5 3.5%	0 0.0%	3 2.5%	0 0.0%	1 1.7%
Phosphorus (Grade 3)	5 3.5%	2 1.4%	2 1.7%	1 1.6%	1 1.7%
Phosphorus (Grade 4)	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
Absolute neutrophil (Grade 3)	2 1.4%	3 2.1%	3 2.5%	0 0.0%	1 1.7%
Absolute neutrophil (Grade 4)	2 1.4%	1 0.7%	1 0.8%	1 1.6%	1 1.7%

11. Secondary Outcome

Title	Number of Participants With Clinically Abnormal in Electrocardiogram (ECG) Findings
Description	A 12-lead ECG was performed. ECG results were reviewed by the Investigator for clinically notable abnormalities.
Time Frame	Years 1 and 2

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.

Arm/Group Title	CVC 150 mg/CVC 150 mg	Placebo/CVC 150 mg	Placebo/Placebo
Arm/Group Description:	CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.	Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.	Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
Overall Number of Participants Analyzed	144	72	72
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%

12. Secondary Outcome

Title	Number of Participants With Hepatic Histological Improvement in NAS at Year 2
Description	Hepatic histological improvement in NAS at Year 2 was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	72	215
Measure Type: Count of Participants; Unit of Measure: Participants
	7 9.7%	24 11.2%

13. Secondary Outcome

Title	Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 1
Description	NAS was calculated using the following 3 categorical features: steatosis which was scaled from 0-3 (steatosis score is defined as 0= <5%, 1= 5 - 33%, 2= >33 - 66%, and 3= >66%), lobular inflammation which was scaled from 0-3 (lobular inflammation score defined as 0= no foci, 1= < 2 foci/200x, 2= 2-4 foci/200x, and 3= > 4 foci/200x), and hepatocellular ballooning which was scaled from 0-2 (hepatocellular ballooning score is defined as 0=none, 1=few balloon cells, 2=many cells/prominent ballooning). A negative change from Baseline indicates improvement.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	126	126
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline (Steatosis)	1.4 (0.55)	1.3 (0.57)
Change from Baseline (Steatosis)	-0.1 (0.66)	-0.2 (0.56)
Baseline (Lobular Inflammation)	2.5 (0.56)	2.4 (0.58)
Change from Baseline (Lobular Inflammation)	-0.1 (0.79)	-0.1 (0.88)
Baseline (Hepatocellular Ballooning)	1.5 (0.50)	1.5 (0.50)
Change from Baseline (Hepatocellular Ballooning)	-0.2 (0.75)	-0.1 (0.75)

14. Secondary Outcome

Title	Change From Baseline in the 3 Categorical Features of NAS (Steatosis, Lobular Inflammation, Hepatocellular Ballooning) at Year 2
Description	NAS was calculated using the following 3 categorical features: steatosis which was scaled from 0-3 (steatosis score is defined as 0= <5%, 1= 5 - 33%, 2= >33 - 66%, and 3= >66%), lobular inflammation which was scaled from 0-3 (lobular inflammation score defined as 0= no foci, 1= < 2 foci/200x, 2= 2-4 foci/200x, and 3= > 4 foci/200x), and hepatocellular ballooning which was scaled from 0-2 (hepatocellular ballooning score is defined as 0=none, 1=few balloon cells, 2=many cells/prominent ballooning). A negative change from Baseline indicates improvement.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	54	159
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline (Steatosis)	1.5 (0.54)	1.3 (0.52)
Change from Baseline (Steatosis)	-0.4 (0.56)	-0.2 (0.50)
Baseline (Lobular Inflammation)	2.4 (0.63)	2.4 (0.54)
Change from Baseline (Lobular Inflammation)	0.1 (0.72)	0.0 (0.84)
Baseline (Hepatocellular Ballooning)	1.5 (0.50)	1.5 (0.50)
Change from Baseline (Hepatocellular Ballooning)	-0.1 (0.68)	0.0 (0.83)

15. Secondary Outcome

Title	Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-Point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1
Description	Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either steatosis, lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Worsening was defined as progression of NASH CRN fibrosis stage.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	143	144
Measure Type: Count of Participants; Unit of Measure: Participants
	24 16.8%	22 15.3%

16. Secondary Outcome

Title	Number of Participants With Hepatic Histological Improvement With a Minimum 2-Point Improvement in NAS With at Least a 1-point Improvement in More Than 1 Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2
Description	Hepatic histological improvement in NAS was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either steatosis, lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating more aggressive disease. Worsening was defined as progression of NASH CRN fibrosis stage.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	72	215
Measure Type: Count of Participants; Unit of Measure: Participants
	6 8.3%	20 9.3%

17. Secondary Outcome

Title	Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 1
Description	Resolution of NASH was defined as having no hepatocellular ballooning (grade 0) and minimal to no lobular inflammation (grade 1 or 0) with no concurrent worsening of fibrosis stage (worsening defined as progression of NASH CRN fibrosis stage).
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	143	144
Measure Type: Count of Participants; Unit of Measure: Participants
	7 4.9%	6 4.2%

18. Secondary Outcome

Title	Number of Participants With Resolution of NASH Using a Modified Definition Based on Categorical Features of NAS and no Concurrent Worsening of Fibrosis Stage at Year 2
Description	Resolution of NASH was defined as having no hepatocellular ballooning (grade 0) and minimal to no lobular inflammation (grade 1 or 0) with no concurrent worsening of fibrosis stage (worsening defined as progression of NASH CRN fibrosis stage).
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	72	215
Measure Type: Count of Participants; Unit of Measure: Participants
	1 1.4%	9 4.2%

19. Secondary Outcome

Title	Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 1
Description	The morphometric quantitative collagen on liver biopsy was determined as percent collagen area (PCA) using Sirius red stain on liver biopsy at Year 1. A negative change from Baseline indicates improvement.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	123	121
Mean (Standard Deviation); Unit of Measure: percent collagen area
Baseline	2.49 (2.004)	2.37 (1.827)
Change from Baseline to Year 1	-0.14 (2.389)	0.02 (2.357)

20. Secondary Outcome

Title	Change From Baseline in Morphometric Quantitative Collagen on Liver Biopsy at Year 2
Description	The morphometric quantitative collagen on liver biopsy was determined as percent collagen area (PCA) using Sirius red stain on liver biopsy at Year 2. A negative change from Baseline indicates improvement.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	51	150
Mean (Standard Deviation); Unit of Measure: percent collagen area
Baseline	2.57 (2.156)	2.48 (1.892)
Change from Baseline to Year 2	-0.17 (2.576)	-0.09 (2.160)

21. Secondary Outcome

Title	Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (α-SMA) at Year 1
Description	The hepatic tissue fibrogenic protein α-SMA level was determined as percent α-SMA + area using α-SMA stain on liver biopsy at Year 1. A positive change from Baseline indicates worsening.
Time Frame	Baseline (Day 1) to Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	122	122
Mean (Standard Deviation); Unit of Measure: percentage of α-SMA positive cells/area
Baseline	2.41 (2.264)	2.49 (2.885)
Change from Baseline to Year 1	0.77 (3.529)	0.79 (3.861)

22. Secondary Outcome

Title	Change From Baseline in Hepatic Tissue Fibrogenic Protein Alpha-Smooth Muscle Actin (α-SMA) at Year 2
Description	The hepatic tissue fibrogenic protein α-SMA level was determined as percent α-SMA + area using α-SMA stain on liver biopsy at Year 2. A positive change from Baseline indicates worsening.
Time Frame	Baseline (Day 1) to Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	52	152
Mean (Standard Deviation); Unit of Measure: percentage of α-SMA positive cells/area
Baseline	2.47 (2.679)	2.44 (2.505)
Change from Baseline to Year 2	2.10 (4.533)	1.38 (3.793)

23. Secondary Outcome

Title	Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 1
Description	The morphometric quantitative fat content was done to find out the amount of fat accumulated in the liver. A liver biopsy was performed to determine percent fat area, at Year 1. A negative change from Baseline indicates improvement.
Time Frame	Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	123	121
Mean (Standard Deviation); Unit of Measure: percent fat area
Baseline	22.42 (10.016)	21.58 (8.740)
Change from Baseline to Year 1	-3.39 (9.120)	-2.79 (8.127)

24. Secondary Outcome

Title	Change From Baseline in Morphometric Quantitative Fat Content on Liver Biopsy at Year 2
Description	The morphometric quantitative fat content was done to find out the amount of fat accumulated in the liver. A liver biopsy was performed to determine percent fat area, at Year 2. A negative change from Baseline indicates improvement.
Time Frame	Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	50	150
Mean (Standard Deviation); Unit of Measure: percent fat area
Baseline	23.30 (10.300)	21.62 (9.575)
Change from Baseline to Year 2	-5.06 (9.739)	-2.96 (9.230)

25. Secondary Outcome

Title	Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 1
Description	The participant's histologic fibrosis stage was determined using the NASH CRN system and Ishak scale score assessment at Year 1. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 where, 0=None to 4=Cirrhosis. The histologic fibrosis stage based on the Ishak assessment was divided into 1 to 6 stages. Fibrosis was staged with the Ishak scale (ranging from 0=No fibrosis to 6=Cirrhosis). A positive change from Baseline indicates worsening.
Time Frame	Baseline (Day 1) to Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	126	126
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline (NASH CRN Fibrosis Stage)	2.1 (0.86)	2.0 (0.85)
Change from Baseline (NASH CRN Fibrosis Stage)	0.2 (0.92)	0.0 (1.00)
Baseline (Ishak Fibrosis Stage)	2.2 (1.00)	2.2 (1.05)
Change from Baseline (Ishak Fibrosis Stage)	0.2 (1.10)	0.0 (1.20)

26. Secondary Outcome

Title	Change From Baseline in Histologic Fibrosis Stage (NASH CRN System and Ishak Scale Score) at Year 2
Description	The participant's histologic fibrosis stage was determined using the NASH CRN system and Ishak scale score assessment at Year 1. The evaluation of fibrosis stage associated with NASH was based on the NASH CRN Fibrosis Staging System which was scaled from 0 to 4 where, 0=None to 4=Cirrhosis. The histologic fibrosis stage based on the Ishak assessment was divided into 1 to 6 stages. Fibrosis was staged with the Ishak scale (ranging from 0=No fibrosis to 6=Cirrhosis). A negative change from Baseline indicates improvement.
Time Frame	Baseline (Day 1) to Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	54	159
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline (NASH CRN Fibrosis Stage)	2.0 (0.88)	2.1 (0.85)
Change from Baseline (NASH CRN Fibrosis Stage)	0.0 (0.89)	0.0 (1.08)
Baseline (Ishak Fibrosis Stage)	2.1 (1.00)	2.2 (1.04)
Change from Baseline (Ishak Fibrosis Stage)	0.1 (1.21)	0.0 (1.26)

27. Secondary Outcome

Title	Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 1
Description	Portal inflammation on liver biopsy was graded from 0 to 4 where 0= None, 1= Mild, 2= Moderate, and 3= Marked. A positive change from Baseline indicates worsening.
Time Frame	Baseline (Day 1) to Year 1

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed	126	124
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	1.6 (0.63)	1.5 (0.64)
Change from Baseline to Year 1	0.0 (0.76)	0.2 (0.74)

28. Secondary Outcome

Title	Change From Baseline in Portal Inflammation Grade on Liver Biopsy at Year 2
Description	Portal inflammation on liver biopsy was graded from 0 to 4 where 0= None, 1= Mild, 2= Moderate, and 3= Marked. A positive change from Baseline indicates worsening.
Time Frame	Baseline (Day 1) to Year 2

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at the given time-point.

Arm/Group Title	Placebo	CVC 150 mg
Arm/Group Description:	Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed	54	159
Mean (Standard Deviation); Unit of Measure: score on a scale
Baseline	1.5 (0.64)	1.6 (0.67)
Change from Baseline to Year 1	0.1 (0.75)	0.2 (0.72)

29. Secondary Outcome

Title	Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 3, 6 and 12
Description	APRI is the ratio of aspartate aminotransferase (AST) to platelet count. It is calculated using formula, APRI = (AST level [/ULN] / platelet counts [10^9/L]) * 100. An APRI index of <=0.50 indicated the absence of significant fibrosis and an index of > 1.50 indicated the presence of significant fibrosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame	Baseline (Month 0) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		143	144
Mean (Standard Deviation); Unit of Measure: ratio
Baseline (Month 3)	Number Analyzed	127 participants	133 participants
		0.649 (0.3661)	0.596 (0.4089)
Change from Baseline to Month 3	Number Analyzed	127 participants	133 participants
		-0.005 (0.3012)	0.065 (0.3152)
Baseline (Month 6)	Number Analyzed	128 participants	127 participants
		0.663 (0.3811)	0.578 (0.3794)
Change from Baseline to Month 6	Number Analyzed	128 participants	127 participants
		0.009 (0.3968)	0.102 (0.4536)
Baseline (Month 12)	Number Analyzed	117 participants	117 participants
		0.662 (0.3915)	0.580 (0.3939)
Change from Baseline to Month 12	Number Analyzed	117 participants	117 participants
		0.066 (0.5572)	0.093 (0.3852)

30. Secondary Outcome

Title	Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Aspartate Aminotransferase to Platelet Count Ratio Index (APRI) at Months 15, 18 and 24
Description	APRI is the ratio of aspartate aminotransferase (AST) to platelet count. It is calculated using formula, APRI = (AST level [/ULN] / platelet counts [10^9/L]) * 100. An APRI index of <=0.50 indicated the absence of significant fibrosis and an index of > 1.50 indicated the presence of significant fibrosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame	Baseline (Month 0) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		72	215
Mean (Standard Deviation); Unit of Measure: ratio
Baseline (Month 15)	Number Analyzed	59 participants	167 participants
		0.619 (0.3157)	0.584 (0.3572)
Change from Baseline to Month 15	Number Analyzed	59 participants	167 participants
		0.002 (0.3422)	0.118 (0.4095)
Baseline (Month 18)	Number Analyzed	53 participants	167 participants
		0.620 (0.3305)	0.586 (0.3612)
Change from Baseline to Month 18	Number Analyzed	53 participants	167 participants
		0.038 (0.4033)	0.133 (0.4269)
Baseline (Month 24)	Number Analyzed	56 participants	158 participants
		0.633 (0.3156)	0.584 (0.3617)
Change from Baseline to Month 24	Number Analyzed	56 participants	158 participants
		-0.020 (0.4721)	0.086 (0.4153)

31. Secondary Outcome

Title	Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 3, 6 and 12
Description	Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. A positive change from Baseline indicates increased fibrosis.
Time Frame	Baseline (Month 0) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		143	144
Mean (Standard Deviation); Unit of Measure: ratio
Baseline (Month 3)	Number Analyzed	127 participants	133 participants
		1.444 (0.6753)	1.417 (0.6893)
Change from Baseline to Month 3	Number Analyzed	127 participants	133 participants
		0.021 (0.4236)	0.071 (0.4209)
Baseline (Month 6)	Number Analyzed	128 participants	127 participants
		1.500 (0.7268)	1.388 (0.6771)
Change from Baseline to Month 6	Number Analyzed	128 participants	127 participants
		0.015 (0.4591)	0.099 (0.5246)
Baseline (Month 12)	Number Analyzed	117 participants	117 participants
		1.503 (0.7442)	1.398 (0.6834)
Change from Baseline to Month 12	Number Analyzed	117 participants	117 participants
		0.106 (0.6876)	0.117 (0.5069)

32. Secondary Outcome

Title	Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Fibrosis-4 (FIB-4) at Months 15, 18 and 24
Description	Fibrosis-4 is the ratio of age in years and aminotransferase to platelet count. It is a non-invasive hepatic fibrosis index score combining standard biochemical values, platelets, alanine aminotransferase (ALT), AST and age that is calculated using formula: FIB-4 = (Age [years] x AST [U/L]) / (platelets [10^9/L] x (square root of ALT [U/L])). A FIB-4 index of < 1.45 indicated no or moderate fibrosis and an index of > 3.25 indicated extensive fibrosis/cirrhosis. A positive change from Baseline indicates increased fibrosis.
Time Frame	Baseline (Month 0) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		72	215
Mean (Standard Deviation); Unit of Measure: ratio
Baseline (Month 15)	Number Analyzed	59 participants	167 participants
		1.409 (0.6706)	1.440 (0.6714)
Change from Baseline to Month 15	Number Analyzed	59 participants	167 participants
		0.075 (0.5982)	0.213 (0.6462)
Baseline (Month 18)	Number Analyzed	53 participants	167 participants
		1.389 (0.6699)	1.440 (0.6895)
Change from Baseline to Month 18	Number Analyzed	53 participants	167 participants
		0.094 (0.5891)	0.219 (0.5559)
Baseline (Month 24)	Number Analyzed	56 participants	158 participants
		1.426 (0.6841)	1.444 (0.6838)
Change from Baseline to Month 24	Number Analyzed	56 participants	158 participants
		0.064 (0.8103)	0.166 (0.6086)

33. Secondary Outcome

Title	Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 6 and 12
Description	Hyaluronic acid is a non-invasive hepatic fibrosis marker. A negative change from Baseline indicates decreased fibrosis.
Time Frame	Baseline (Month 0) to Months 6 and 12

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		143	144
Mean (Standard Deviation); Unit of Measure: ng/mL
Baseline (Month 6)	Number Analyzed	128 participants	128 participants
		68.7 (107.63)	68.2 (78.88)
Change from Baseline to Month 6	Number Analyzed	128 participants	128 participants
		-2.4 (75.03)	10.7 (79.58)
Baseline (Month 12)	Number Analyzed	122 participants	121 participants
		70.7 (110.49)	69.5 (80.56)
Change from Baseline to Month 12	Number Analyzed	122 participants	121 participants
		-0.2 (81.30)	10.9 (58.46)

34. Secondary Outcome

Title	Change From Baseline in Non-invasive Marker of Hepatic Fibrosis: Hyaluronic Acid at Months 18 and 24
Description	Hyaluronic acid is a non-invasive hepatic fibrosis marker. A positive change from Baseline indicates increased fibrosis.
Time Frame	Baseline (Month 0) to Months 18 and 24

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		72	215
Mean (Standard Deviation); Unit of Measure: ng/mL
Baseline (Month 18)	Number Analyzed	58 participants	170 participants
		46.4 (32.67)	79.6 (111.36)
Change from Baseline to Month 18	Number Analyzed	58 participants	170 participants
		5.7 (34.66)	1.4 (81.20)
Baseline (Month 24)	Number Analyzed	57 participants	164 participants
		46.6 (32.91)	79.7 (112.46)
Change from Baseline to Month 24	Number Analyzed	57 participants	164 participants
		19.3 (70.64)	13.0 (95.00)

35. Secondary Outcome

Title	Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Nonalcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) at Months 3, 6 and 12
Description	NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * Body mass index (BMI) (kg/m^2) + 1.13 * Impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio - 0.013 × platelet (*10^9/L) - 0.66 * albumin (g/dL). A negative change from Baseline indicates decreased fibrosis.
Time Frame	Baseline (Month 0) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		143	144
Mean (Standard Deviation); Unit of Measure: ng/mL
Baseline (Month 3)	Number Analyzed	125 participants	125 participants
		-1.227 (1.5255)	-1.012 (1.2558)
Change from Baseline to Month 3	Number Analyzed	125 participants	125 participants
		0.029 (0.5150)	0.087 (0.4608)
Baseline (Month 6)	Number Analyzed	125 participants	119 participants
		-1.119 (1.4935)	-1.064 (1.2403)
Change from Baseline to Month 6	Number Analyzed	125 participants	119 participants
		0.051 (0.4747)	0.094 (0.5460)
Baseline (Month 12)	Number Analyzed	115 participants	108 participants
		-1.132 (1.4609)	-1.040 (1.1393)
Change from Baseline to Month 12	Number Analyzed	115 participants	108 participants
		0.121 (0.5117)	0.139 (0.5016)

36. Secondary Outcome

Title	Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: NAFLD Fibrosis Score (NFS) at Months 15, 18 and 24
Description	NFS is calculated using formula: NFS = -1.675 + 0.037 * age (years) + 0.094 * Body mass index (BMI) (kg/m^2) + 1.13 * Impaired fasting glucose (IFG)/diabetes (yes = 1, no = 0) + 0.99 * Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT) ratio - 0.013 × platelet (*10^9/L) - 0.66 * albumin (g/dL). A negative change from Baseline indicates decreased fibrosis.
Time Frame	Baseline (Month 0) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		72	215
Mean (Standard Deviation); Unit of Measure: ng/mL
Baseline (Month 15)	Number Analyzed	59 participants	158 participants
		-1.252 (1.4602)	-1.051 (1.3410)
Change from Baseline to Month 15	Number Analyzed	59 participants	158 participants
		0.057 (0.5981)	0.225 (0.5654)
Baseline (Month 18)	Number Analyzed	53 participants	158 participants
		-1.284 (1.4910)	-1.057 (1.3309)
Change from Baseline to Month 18	Number Analyzed	53 participants	158 participants
		0.046 (0.5809)	0.196 (0.5583)
Baseline (Month 24)	Number Analyzed	54 participants	147 participants
		-1.245 (1.4778)	-1.100 (1.3228)
Change from Baseline to Month 24	Number Analyzed	54 participants	147 participants
		0.046 (0.6188)	0.185 (0.6184)

37. Secondary Outcome

Title	Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 6 and 12
Description	The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on Centaur device and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame	Baseline (Month 0) to Months 6 and 12

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		143	144
Mean (Standard Deviation); Unit of Measure: ng/mL
Baseline (Month 6)	Number Analyzed	125 participants	125 participants
		-0.786 (0.7179)	-0.837 (0.7238)
Change from Baseline to Month 6	Number Analyzed	125 participants	125 participants
		-0.022 (0.4901)	0.060 (0.5228)
Baseline (Month 12)	Number Analyzed	116 participants	118 participants
		-0.795 (0.7435)	-0.801 (0.7162)
Change from Baseline to Month 12	Number Analyzed	116 participants	118 participants
		-0.064 (0.5602)	0.041 (0.5727)

38. Secondary Outcome

Title	Change From Baseline in Non-invasive Markers of Hepatic Fibrosis: Enhanced Liver Fibrosis Test (ELF) Score at Months 18 and 24
Description	The markers of fibrosis assessed in this test comprised hyaluronic acid (CHA), tissue inhibitor of metalloproteinase (CTIMP1) and procollagen III N-terminal peptide (CP3NP); these are components of the extracellular matrix and basement sinusoidal membrane of the liver and are elevated during activation of the stellate cell. The ELF tests were performed on Centaur device and the composite score was calculated as follows: ELF score = 2.278 + 0.851 ln(CHA) + 0.751 ln (CP3NP) + 0.394 ln(CTIMP1). ELF score < 7.7: no to mild fibrosis; ≥ 7.7 - < 9.8: Moderate fibrosis; ≥ 9.8 - < 11.3: Severe fibrosis; ≥ 11.3: Cirrhosis. A negative change from Baseline indicates decreased fibrosis.
Time Frame	Baseline (Month 0) to Months 18 and 24

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		72	215
Mean (Standard Deviation); Unit of Measure: ng/mL
Baseline (Month 18)	Number Analyzed	57 participants	164 participants
		-0.931 (0.6387)	-0.758 (0.7307)
Change from Baseline to Month 18	Number Analyzed	57 participants	164 participants
		-0.129 (0.6606)	-0.087 (0.6113)
Baseline (Month 24)	Number Analyzed	56 participants	157 participants
		-0.940 (0.6587)	-0.765 (0.7127)
Change from Baseline to Month 24	Number Analyzed	56 participants	157 participants
		-0.024 (0.7375)	0.096 (0.6437)

39. Secondary Outcome

Title	Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 3, 6 and 12
Description	Caspase-cleaved cytokeratin levels (CK18M30) and total M-65 (CK-18 [M-65]) were measured as biomarkers of hepatocyte apoptosis. A negative change from Baseline indicates decreased hepatocyte apoptosis.
Time Frame	Baseline (Month 0) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

FAS in Year 1 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		143	144
Mean (Standard Deviation); Unit of Measure: U/L
Baseline (Month 3)	Number Analyzed	115 participants	119 participants
		601.6 (431.77)	594.2 (554.20)
Change from Baseline to Month 3	Number Analyzed	115 participants	119 participants
		-56.4 (451.14)	-59.0 (485.76)
Baseline (Month 6)	Number Analyzed	105 participants	107 participants
		550.3 (360.64)	552.9 (393.92)
Change from Baseline to Month 6	Number Analyzed	105 participants	107 participants
		10.6 (461.98)	-26.1 (512.88)
Baseline (Month 12)	Number Analyzed	107 participants	101 participants
		555.3 (356.28)	567.9 (500.53)
Change from Baseline to Month 12	Number Analyzed	107 participants	101 participants
		99.7 (824.50)	107.8 (830.28)

40. Secondary Outcome

Title	Change From Baseline in Biomarkers of Hepatocyte Apoptosis: Caspase Cleaved (CK-18 [M-30]) Levels and Total M-65 (CK-18 [M-65]) Levels at Months 15, 18 and 24
Description	Caspase-cleaved cytokeratin levels (CK18M30) and total M-65 (CK-18 [M-65]) were measured as biomarkers of hepatocyte apoptosis. A negative change from Baseline indicates decreased hepatocyte apoptosis.
Time Frame	Baseline (Month 0) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

FAS in Year 2 included all participants who were randomized and received at least 1 dose of study drug, had a measurable Screening biopsy, and had no major eligibility violations. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		72	215
Mean (Standard Deviation); Unit of Measure: U/L
CK-18(M30), Baseline (Month 15)	Number Analyzed	51 participants	145 participants
		570.8 (297.42)	536.4 (459.06)
CK-18(M30), Change from Baseline to Month 15	Number Analyzed	51 participants	145 participants
		-39.6 (287.44)	-13.3 (450.16)
CK-18(M30), Baseline (Month 18)	Number Analyzed	51 participants	149 participants
		578.8 (293.93)	540.9 (453.90)
CK-18(M30), Change from Baseline to Month 18	Number Analyzed	51 participants	149 participants
		23.8 (402.98)	57.3 (476.92)
CK-18(M30), Baseline (Month 24)	Number Analyzed	50 participants	143 participants
		575.4 (293.64)	541.8 (462.29)
CK-18(M30), Change from Baseline to Month 24	Number Analyzed	50 participants	143 participants
		-30.0 (369.60)	39.7 (437.60)
CK-18(M65), Baseline (Month 15)	Number Analyzed	51 participants	145 participants
		772.7 (337.24)	687.4 (404.83)
CK-18(M65), Change from Baseline to Month 15	Number Analyzed	51 participants	145 participants
		134.7 (534.46)	88.6 (559.11)
CK-18(M65), Baseline (Month 18)	Number Analyzed	51 participants	149 participants
		777.8 (344.07)	694.8 (401.88)
CK-18(M65), Change from Baseline to Month 18	Number Analyzed	51 participants	149 participants
		158.0 (732.63)	181.5 (620.57)
CK-18(M65), Baseline (Month 24)	Number Analyzed	50 participants	143 participants
		770.2 (335.05)	693.9 (409.88)
CK-18(M65), Change from Baseline to Month 24	Number Analyzed	50 participants	143 participants
		7.4 (570.92)	124.9 (522.08)

41. Secondary Outcome

Title	Change From Baseline in Weight at Months 3, 6 and 12
Description	A negative change from Baseline represents decreased weight.
Time Frame	Baseline (Day 1) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		144	144
Mean (Standard Deviation); Unit of Measure: kg
Baseline (Month 3)	Number Analyzed	133 participants	138 participants
		97.21 (22.368)	95.59 (20.590)
Change from Baseline to Month 3	Number Analyzed	133 participants	138 participants
		-0.50 (2.652)	-0.63 (2.632)
Baseline (Month 6)	Number Analyzed	130 participants	132 participants
		97.18 (22.224)	95.18 (20.386)
Change from Baseline to Month 6	Number Analyzed	130 participants	132 participants
		-0.55 (3.319)	-0.47 (3.466)
Baseline (Month 12)	Number Analyzed	126 participants	122 participants
		96.63 (22.139)	95.06 (20.651)
Change from Baseline to Month 12	Number Analyzed	126 participants	122 participants
		-0.08 (4.301)	-0.28 (4.166)

42. Secondary Outcome

Title	Change From Baseline in Weight at Months 15, 18 and 24
Description	A negative change from Baseline represents decreased weight.
Time Frame	Baseline (Day 1) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		60	182
Mean (Standard Deviation); Unit of Measure: kg
Baseline (Month 15)	Number Analyzed	59 participants	174 participants
		98.25 (24.087)	95.32 (20.749)
Change from Baseline to Month 15	Number Analyzed	59 participants	174 participants
		0.15 (3.448)	-0.44 (4.257)
Baseline (Month 18)	Number Analyzed	58 participants	173 participants
		96.98 (22.210)	95.23 (20.823)
Change from Baseline to Month 18	Number Analyzed	58 participants	173 participants
		0.05 (4.194)	-0.16 (4.458)
Baseline (Month 24)	Number Analyzed	58 participants	166 participants
		96.98 (22.210)	95.19 (20.972)
Change from Baseline to Month 24	Number Analyzed	58 participants	166 participants
		-0.91 (5.649)	-0.56 (5.081)

43. Secondary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Months 3, 6 and 12
Description	The body mass index is a value derived from the mass (weight in kgs) and height (in centimeters) of an individual and is calculated as the body mass divided by the square of the body height. A negative change from Baseline represents decreased BMI.
Time Frame	Baseline (Day 1) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		144	144
Mean (Standard Deviation); Unit of Measure: kg/m^2
Baseline (Month 3)	Number Analyzed	133 participants	135 participants
		34.129 (7.2492)	33.706 (5.7812)
Change from Baseline to Month 3	Number Analyzed	133 participants	135 participants
		-0.172 (0.9200)	-0.232 (0.9500)
Baseline (Month 6)	Number Analyzed	130 participants	129 participants
		34.196 (7.3086)	33.547 (5.6037)
Change from Baseline to Month 6	Number Analyzed	130 participants	129 participants
		-0.182 (1.1558)	-0.196 (1.2500)
Baseline (Month 12)	Number Analyzed	126 participants	119 participants
		34.029 (7.1358)	33.374 (5.6631)
Change from Baseline to Month 12	Number Analyzed	126 participants	119 participants
		-0.013 (1.7507)	-0.145 (1.4891)

44. Secondary Outcome

Title	Change From Baseline in Body Mass Index (BMI) at Months 15, 18 and 24
Description	The body mass index is a value derived from the mass (weight in kgs) and height (in centimeters) of an individual and is calculated as the body mass divided by the square of the body height. A negative change from Baseline represents decreased BMI.
Time Frame	Baseline (Day 1) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		60	182
Mean (Standard Deviation); Unit of Measure: kg/m^2
Baseline (Month 15)	Number Analyzed	59 participants	171 participants
		34.713 (8.0431)	33.392 (5.9669)
Change from Baseline to Month 15	Number Analyzed	59 participants	171 participants
		-0.006 (1.2799)	-0.113 (1.6311)
Baseline (Month 18)	Number Analyzed	58 participants	170 participants
		34.473 (7.8964)	33.345 (5.9443)
Change from Baseline to Month 18	Number Analyzed	58 participants	170 participants
		-0.039 (1.5931)	-0.040 (1.7153)
Baseline (Month 24)	Number Analyzed	58 participants	163 participants
		34.473 (7.8964)	33.278 (6.0012)
Change from Baseline to Month 24	Number Analyzed	58 participants	163 participants
		-0.393 (2.0613)	-0.178 (1.8515)

45. Secondary Outcome

Title	Change From Baseline in Waist Circumference at Months 3, 6 and 12
Description	A negative change from Baseline represents decreased in waist circumference.
Time Frame	Baseline (Day 1) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		144	144
Mean (Standard Deviation); Unit of Measure: cm
Baseline (Month 3)	Number Analyzed	131 participants	135 participants
		110.35 (14.866)	110.25 (13.406)
Change from Baseline to Month 3	Number Analyzed	131 participants	135 participants
		0.07 (5.147)	0.05 (5.396)
Baseline (Month 6)	Number Analyzed	129 participants	129 participants
		110.42 (14.986)	110.12 (13.561)
Change from Baseline to Month 6	Number Analyzed	129 participants	129 participants
		0.42 (8.827)	-0.54 (5.876)
Baseline (Month 12)	Number Analyzed	123 participants	118 participants
		109.77 (14.617)	110.02 (13.711)
Change from Baseline to Month 12	Number Analyzed	123 participants	118 participants
		0.44 (6.584)	-1.10 (6.255)

46. Secondary Outcome

Title	Change From Baseline in Waist Circumference at Months 15, 18 and 24
Description	A negative change from Baseline represents decreased in waist circumference.
Time Frame	Baseline (Day 1) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		60	182
Mean (Standard Deviation); Unit of Measure: cm
Baseline (Month 15)	Number Analyzed	57 participants	172 participants
		110.19 (14.360)	110.26 (14.486)
Change from Baseline to Month 15	Number Analyzed	57 participants	172 participants
		0.52 (5.520)	-0.18 (6.280)
Baseline (Month 18)	Number Analyzed	56 participants	170 participants
		109.48 (12.703)	110.25 (14.517)
Change from Baseline to Month 18	Number Analyzed	56 participants	170 participants
		1.36 (7.966)	-0.21 (6.578)
Baseline (Month 24)	Number Analyzed	58 participants	163 participants
		109.36 (12.608)	110.08 (14.606)
Change from Baseline to Month 24	Number Analyzed	58 participants	163 participants
		0.11 (7.907)	-1.00 (6.503)

47. Secondary Outcome

Title	Change From Baseline in Hip Circumference at Months 3, 6 and 12
Description	A negative change from Baseline represents decreased hip circumference.
Time Frame	Baseline (Day 1) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		144	144
Mean (Standard Deviation); Unit of Measure: cm
Baseline (Month 3)	Number Analyzed	129 participants	130 participants
		114.92 (16.150)	112.35 (13.802)
Change from Baseline to Month 3	Number Analyzed	129 participants	130 participants
		-0.30 (4.921)	-0.11 (6.475)
Baseline (Month 6)	Number Analyzed	127 participants	124 participants
		115.09 (16.270)	112.16 (13.320)
Change from Baseline to Month 6	Number Analyzed	127 participants	124 participants
		-0.84 (4.396)	-0.18 (5.715)
Baseline (Month 12)	Number Analyzed	121 participants	113 participants
		114.46 (15.970)	111.66 (13.376)
Change from Baseline to Month 12	Number Analyzed	121 participants	113 participants
		-0.25 (5.876)	-0.08 (7.474)

48. Secondary Outcome

Title	Change From Baseline in Hip Circumference at Months 15, 18 and 24
Description	A negative change from Baseline represents decreased hip circumference.
Time Frame	Baseline (Day 1) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		60	182
Mean (Standard Deviation); Unit of Measure: cm
Baseline (Month 15)	Number Analyzed	58 participants	165 participants
		114.56 (17.500)	113.00 (14.183)
Change from Baseline to Month 15	Number Analyzed	58 participants	165 participants
		-0.06 (5.361)	-0.83 (7.050)
Baseline (Month 18)	Number Analyzed	55 participants	162 participants
		114.28 (17.871)	112.70 (14.168)
Change from Baseline to Month 18	Number Analyzed	55 participants	162 participants
		0.55 (7.791)	-0.90 (6.066)
Baseline (Month 24)	Number Analyzed	58 participants	157 participants
		114.34 (17.408)	112.88 (14.225)
Change from Baseline to Month 24	Number Analyzed	58 participants	157 participants
		-0.95 (7.700)	-1.21 (6.677)

49. Secondary Outcome

Title	Change From Baseline in Forearm Circumference at Months 3, 6 and 12
Description	A negative change from Baseline represents decreased forearm circumference.
Time Frame	Baseline (Day 1) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		144	144
Mean (Standard Deviation); Unit of Measure: cm
Baseline (Month 3)	Number Analyzed	127 participants	132 participants
		32.95 (7.346)	33.38 (4.835)
Change from Baseline to Month 3	Number Analyzed	127 participants	132 participants
		0.97 (6.023)	0.10 (6.486)
Baseline (Month 6)	Number Analyzed	126 participants	126 participants
		32.70 (7.290)	33.25 (4.734)
Change from Baseline to Month 6	Number Analyzed	126 participants	126 participants
		0.82 (6.748)	-0.01 (3.447)
Baseline (Month 12)	Number Analyzed	120 participants	115 participants
		32.51 (7.277)	33.09 (4.771)
Change from Baseline to Month 12	Number Analyzed	120 participants	115 participants
		0.83 (6.656)	-0.43 (3.516)

50. Secondary Outcome

Title	Change From Baseline in Forearm Circumference at Months 15, 18 and 24
Description	A negative change from Baseline represents decreased forearm circumference.
Time Frame	Baseline (Day 1) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		60	182
Mean (Standard Deviation); Unit of Measure: cm
Baseline (Month 15)	Number Analyzed	57 participants	168 participants
		32.88 (7.783)	32.91 (5.662)
Change from Baseline to Month 15	Number Analyzed	57 participants	168 participants
		1.61 (6.534)	0.01 (5.052)
Baseline (Month 18)	Number Analyzed	55 participants	166 participants
		32.63 (7.718)	32.87 (5.696)
Change from Baseline to Month 18	Number Analyzed	55 participants	166 participants
		1.79 (6.715)	0.02 (4.709)
Baseline (Month 24)	Number Analyzed	57 participants	159 participants
		32.79 (7.660)	33.02 (5.561)
Change from Baseline to Month 24	Number Analyzed	57 participants	159 participants
		0.78 (6.124)	-0.64 (4.408)

51. Secondary Outcome

Title	Change From Baseline in Tricep Skinfold Thickness at Months 3, 6 and 12
Description	A negative change from Baseline represents decreased Tricep Skinfold Thickness.
Time Frame	Baseline (Day 1) to Months 3, 6 and 12

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 1 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1.	Cenicriviroc 150 mg tablet, once daily in the morning with food in Year 1.
Overall Number of Participants Analyzed		144	144
Mean (Standard Deviation); Unit of Measure: mm
Baseline (Month 3)	Number Analyzed	127 participants	131 participants
		28.32 (13.677)	25.41 (12.593)
Change from Baseline to Month 3	Number Analyzed	127 participants	131 participants
		-1.21 (6.548)	-0.62 (8.704)
Baseline (Month 6)	Number Analyzed	128 participants	125 participants
		28.53 (13.763)	25.38 (12.769)
Change from Baseline to Month 6	Number Analyzed	128 participants	125 participants
		-2.72 (8.091)	-1.52 (9.287)
Baseline (Month 12)	Number Analyzed	122 participants	115 participants
		28.54 (13.981)	25.14 (12.969)
Change from Baseline to Month 12	Number Analyzed	122 participants	115 participants
		-1.34 (9.389)	-0.26 (10.653)

52. Secondary Outcome

Title	Change From Baseline in Tricep Skinfold Thickness at Months 15, 18 and 24
Description	A negative change from Baseline represents decreased Tricep Skinfold Thickness.
Time Frame	Baseline (Day 1) to Months 15, 18 and 24

Outcome Measure Data

Analysis Population Description

Safety Analysis Set Year 2 included all participants who received at least 1 dose of study drug. Number analyzed is the number of participants with data available for analysis at both Baseline and the given time-point.

Arm/Group Title		Placebo	CVC 150 mg
Arm/Group Description:		Placebo-matching cenicriviroc tablet, once daily in the morning with food in Years 1 and 2.	Cenicriviroc 150 mg tablet or placebo-matching cenicriviroc tablet, once daily in the morning with food in Year 1 then cenicriviroc 150 mg tablet, once daily in the morning with food in Year 2.
Overall Number of Participants Analyzed		60	182
Mean (Standard Deviation); Unit of Measure: mm
Baseline (Month 15)	Number Analyzed	57 participants	170 participants
		29.84 (14.422)	25.41 (13.212)
Change from Baseline to Month 15	Number Analyzed	57 participants	170 participants
		-1.45 (9.364)	-1.59 (8.918)
Baseline (Month 18)	Number Analyzed	55 participants	168 participants
		29.84 (14.655)	25.07 (12.856)
Change from Baseline to Month 18	Number Analyzed	55 participants	168 participants
		-2.27 (8.854)	-2.64 (8.864)
Baseline (Month 24)	Number Analyzed	56 participants	160 participants
		29.91 (14.532)	24.82 (13.025)
Change from Baseline to Month 24	Number Analyzed	56 participants	160 participants
		-3.11 (8.553)	-1.33 (10.521)

Adverse Events

Time Frame	Baseline to Year 2
Adverse Event Reporting Description	Safety Analysis Set Year 1 and Year 2 included all participants who received at least 1 dose of study drug.
Arm/Group Title	CVC 150mg/CVC 150 mg	Placebo/Cenicriviroc (CVC) 150 mg	Placebo/Placebo
Arm/Group Description	CVC 150 mg tablet, once daily in the morning with food in Years 1 and 2.	Placebo-matching CVC tablet, once daily in the morning with food in Year 1 then CVC 150 mg tablet, once daily in the morning with food in Year 2.	Placebo-matching cenicriviroc (CVC) tablet, once daily in the morning with food in Years 1 and 2.
All-Cause Mortality
	CVC 150mg/CVC 150 mg	Placebo/Cenicriviroc (CVC) 150 mg	Placebo/Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/144 (0.00%)	0/72 (0.00%)	0/72 (0.00%)
Serious Adverse Events
	CVC 150mg/CVC 150 mg	Placebo/Cenicriviroc (CVC) 150 mg	Placebo/Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	25/144 (17.36%)	8/72 (11.11%)	12/72 (16.67%)
Blood and lymphatic system disorders
Anaemia † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Cardiac disorders
Acute coronary syndrome † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Acute myocardial infarction † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Arrhythmia † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Cardiac failure congestive † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Coronary artery occlusion † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Myocardial ischaemia † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Gastrointestinal disorders
Inguinal hernia † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Pancreatitis acute † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Abdominal pain upper † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Colitis ischaemic † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Large intestine polyp † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Peritoneal haemorrhage † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Vasculitis gastrointestinal † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
General disorders
Chest pain † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Non-cardiac chest pain † 1	2/144 (1.39%)	0/72 (0.00%)	1/72 (1.39%)
Hepatobiliary disorders
Cholelithiasis † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Infections and infestations
Appendicitis † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Cellulitis † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Diverticulitis † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Gastroenteritis † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Pneumonia † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Sepsis † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Pyelonephritis † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Subcutaneous abscess † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Urosepsis † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Injury, poisoning and procedural complications
Accidental overdose † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Ankle fracture † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Concussion † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Facial bones fracture † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Joint injury † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Laceration † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Lumbar vertebral fracture † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Meniscus injury † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Traumatic haemothorax † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Humerus fracture † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Overdose † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Procedural pain † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Wrist fracture † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Investigations
Blood triglycerides increased † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Metabolism and nutrition disorders
Dehydration † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Type 2 diabetes mellitus † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Hypovolaemia † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Musculoskeletal and connective tissue disorders
Back pain † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Spinal osteoarthritis † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Osteoarthritis † 1	2/144 (1.39%)	0/72 (0.00%)	0/72 (0.00%)
Intervertebral disc protrusion † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Lumbar spinal stenosis † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Psoriatic arthropathy † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Peripheral nerve sheath tumour malignant † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Haemangioma of skin † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Nervous system disorders
Convulsion † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Syncope † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Generalised tonic-clonic seizure † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Loss of consciousness † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Paraesthesia † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
VIIth nerve paralysis † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Psychiatric disorders
Bipolar disorder † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Renal and urinary disorders
Nephrolithiasis † 1	0/144 (0.00%)	1/72 (1.39%)	0/72 (0.00%)
Renal failure † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Renal failure acute † 1	0/144 (0.00%)	1/72 (1.39%)	1/72 (1.39%)
Bladder dysplasia † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Lung disorder † 1	1/144 (0.69%)	0/72 (0.00%)	0/72 (0.00%)
Asthma † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
Vascular disorders
Deep vein thrombosis † 1	0/144 (0.00%)	0/72 (0.00%)	1/72 (1.39%)
1 Term from vocabulary, MedDRA, Version 17.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	CVC 150mg/CVC 150 mg	Placebo/Cenicriviroc (CVC) 150 mg	Placebo/Placebo
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	127/144 (88.19%)	59/72 (81.94%)	60/72 (83.33%)
Gastrointestinal disorders
Diarrhoea † 1	32/144 (22.22%)	14/72 (19.44%)	15/72 (20.83%)
Abdominal pain upper † 1	16/144 (11.11%)	12/72 (16.67%)	10/72 (13.89%)
Abdominal pain † 1	18/144 (12.50%)	6/72 (8.33%)	11/72 (15.28%)
Nausea † 1	28/144 (19.44%)	6/72 (8.33%)	8/72 (11.11%)
Abdominal distension † 1	13/144 (9.03%)	4/72 (5.56%)	0/72 (0.00%)
Constipation † 1	13/144 (9.03%)	4/72 (5.56%)	6/72 (8.33%)
Flatulence † 1	9/144 (6.25%)	3/72 (4.17%)	2/72 (2.78%)
Gastrooesophageal reflux disease † 1	6/144 (4.17%)	3/72 (4.17%)	4/72 (5.56%)
Vomiting † 1	18/144 (12.50%)	3/72 (4.17%)	5/72 (6.94%)
General disorders
Fatigue † 1	24/144 (16.67%)	10/72 (13.89%)	13/72 (18.06%)
Oedema peripheral † 1	5/144 (3.47%)	5/72 (6.94%)	3/72 (4.17%)
Pyrexia † 1	8/144 (5.56%)	4/72 (5.56%)	1/72 (1.39%)
Infections and infestations
Urinary tract infection † 1	17/144 (11.81%)	10/72 (13.89%)	4/72 (5.56%)
Nasopharyngitis † 1	21/144 (14.58%)	9/72 (12.50%)	7/72 (9.72%)
Upper respiratory tract infection † 1	18/144 (12.50%)	9/72 (12.50%)	8/72 (11.11%)
Influenza † 1	11/144 (7.64%)	3/72 (4.17%)	3/72 (4.17%)
Sinusitis † 1	18/144 (12.50%)	3/72 (4.17%)	9/72 (12.50%)
Ear infection † 1	5/144 (3.47%)	2/72 (2.78%)	4/72 (5.56%)
Bronchitis † 1	10/144 (6.94%)	1/72 (1.39%)	7/72 (9.72%)
Gastroenteritis † 1	3/144 (2.08%)	1/72 (1.39%)	4/72 (5.56%)
Injury, poisoning and procedural complications
Procedural pain † 1	5/144 (3.47%)	2/72 (2.78%)	9/72 (12.50%)
Investigations
Alanine aminotransferase increased † 1	15/144 (10.42%)	9/72 (12.50%)	5/72 (6.94%)
Blood creatine phosphokinase increased † 1	3/144 (2.08%)	5/72 (6.94%)	0/72 (0.00%)
Metabolism and nutrition disorders
Type 2 diabetes mellitus † 1	6/144 (4.17%)	5/72 (6.94%)	4/72 (5.56%)
Hyperglycaemia † 1	0/144 (0.00%)	4/72 (5.56%)	2/72 (2.78%)
Musculoskeletal and connective tissue disorders
Back pain † 1	11/144 (7.64%)	11/72 (15.28%)	12/72 (16.67%)
Myalgia † 1	11/144 (7.64%)	5/72 (6.94%)	3/72 (4.17%)
Arthralgia † 1	23/144 (15.97%)	4/72 (5.56%)	4/72 (5.56%)
Muscle spasms † 1	15/144 (10.42%)	4/72 (5.56%)	2/72 (2.78%)
Pain in extremity † 1	14/144 (9.72%)	1/72 (1.39%)	6/72 (8.33%)
Nervous system disorders
Headache † 1	24/144 (16.67%)	15/72 (20.83%)	9/72 (12.50%)
Dizziness † 1	13/144 (9.03%)	0/72 (0.00%)	5/72 (6.94%)
Psychiatric disorders
Insomnia † 1	10/144 (6.94%)	2/72 (2.78%)	2/72 (2.78%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	16/144 (11.11%)	5/72 (6.94%)	6/72 (8.33%)
Oropharyngeal pain † 1	13/144 (9.03%)	3/72 (4.17%)	4/72 (5.56%)
Nasal congestion † 1	8/144 (5.56%)	0/72 (0.00%)	2/72 (2.78%)
Skin and subcutaneous tissue disorders
Pruritus † 1	10/144 (6.94%)	3/72 (4.17%)	5/72 (6.94%)
Rash † 1	12/144 (8.33%)	3/72 (4.17%)	8/72 (11.11%)
Vascular disorders
Hypertension † 1	10/144 (6.94%)	4/72 (5.56%)	3/72 (4.17%)
1 Term from vocabulary, MedDRA, Version 17.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

Results Point of Contact

• Name/Title: Therapeutic Area, Head
• Organization: Allergan
• Phone: 714-246-4500
• EMail: clinicaltrials@allergan.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Qian T, Fujiwara N, Koneru B, Ono A, Kubota N, Jajoriya AK, Tung MG, Crouchet E, Song WM, Marquez CA, Panda G, Hoshida A, Raman I, Li QZ, Lewis C, Yopp A, Rich NE, Singal AG, Nakagawa S, Goossens N, Higashi T, Koh AP, Bian CB, Hoshida H, Tabrizian P, Gunasekaran G, Florman S, Schwarz ME, Hiotis SP, Nakahara T, Aikata H, Murakami E, Beppu T, Baba H, Rew Warren, Bhatia S, Kobayashi M, Kumada H, Fobar AJ, Parikh ND, Marrero JA, Rwema SH, Nair V, Patel M, Kim-Schulze S, Corey K, O'Leary JG, Klintmalm GB, Thomas DL, Dibas M, Rodriguez G, Zhang B, Friedman SL, Baumert TF, Fuchs BC, Chayama K, Zhu S, Chung RT, Hoshida Y. Molecular Signature Predictive of Long-Term Liver Fibrosis Progression to Inform Antifibrotic Drug Development. Gastroenterology. 2022 Apr;162(4):1210-1225. doi: 10.1053/j.gastro.2021.12.250. Epub 2021 Dec 22. Erratum in: Gastroenterology. 2022 Aug;163(2):536.

Nielsen MJ, Leeming DJ, Goodman Z, Friedman S, Frederiksen P, Rasmussen DGK, Vig P, Seyedkazemi S, Fischer L, Torstenson R, Karsdal MA, Lefebvre E, Sanyal AJ, Ratziu V. Comparison of ADAPT, FIB-4 and APRI as non-invasive predictors of liver fibrosis and NASH within the CENTAUR screening population. J Hepatol. 2021 Dec;75(6):1292-1300. doi: 10.1016/j.jhep.2021.08.016. Epub 2021 Aug 27.

Parthasarathy G, Malhi H. Macrophage Heterogeneity in NASH: More Than Just Nomenclature. Hepatology. 2021 Jul;74(1):515-518. doi: 10.1002/hep.31790. Epub 2021 May 22.

Ratziu V, Sanyal A, Harrison SA, Wong VW, Francque S, Goodman Z, Aithal GP, Kowdley KV, Seyedkazemi S, Fischer L, Loomba R, Abdelmalek MF, Tacke F. Cenicriviroc Treatment for Adults With Nonalcoholic Steatohepatitis and Fibrosis: Final Analysis of the Phase 2b CENTAUR Study. Hepatology. 2020 Sep;72(3):892-905. doi: 10.1002/hep.31108. Epub 2020 Jul 21.

Lefebvre E, Moyle G, Reshef R, Richman LP, Thompson M, Hong F, Chou HL, Hashiguchi T, Plato C, Poulin D, Richards T, Yoneyama H, Jenkins H, Wolfgang G, Friedman SL. Antifibrotic Effects of the Dual CCR2/CCR5 Antagonist Cenicriviroc in Animal Models of Liver and Kidney Fibrosis. PLoS One. 2016 Jun 27;11(6):e0158156. doi: 10.1371/journal.pone.0158156. eCollection 2016.

Friedman S, Sanyal A, Goodman Z, Lefebvre E, Gottwald M, Fischer L, Ratziu V. Efficacy and safety study of cenicriviroc for the treatment of non-alcoholic steatohepatitis in adult subjects with liver fibrosis: CENTAUR Phase 2b study design. Contemp Clin Trials. 2016 Mar;47:356-65. doi: 10.1016/j.cct.2016.02.012. Epub 2016 Mar 2.

• Responsible Party: Tobira Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT02217475
• Other Study ID Numbers: 652-2-203; 2016-004754-15 ( EudraCT Number )
• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Results First Submitted: April 19, 2019
• Results First Posted: May 10, 2019
• Last Update Posted: May 10, 2019