Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis (TANDEM)
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ClinicalTrials.gov Identifier: NCT03517540 |
Recruitment Status :
Completed
First Posted : May 7, 2018
Results First Posted : November 12, 2021
Last Update Posted : April 29, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-alcoholic Steatohepatitis (NASH) | Drug: Tropifexor (LJN452) Drug: Cenicriviroc (CVC) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 193 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of a Combination Treatment of Tropifexor (LJN452) and Cenicriviroc (CVC) in Adult Patients With Nonalcoholic Steatohepatitis (NASH) and Liver Fibrosis |
Actual Study Start Date : | September 11, 2018 |
Actual Primary Completion Date : | September 15, 2020 |
Actual Study Completion Date : | October 15, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Arm A: Tropifexor (LJN452) - Dose 1
tropifexor 140 mcg, once daily; given orally
|
Drug: Tropifexor (LJN452)
Comparison with monotherapy and different combination doses
Other Name: LJN452 |
Experimental: Arm B: Cenicriviroc (CVC)
CVC 150 mg, once daily; given orally
|
Drug: Cenicriviroc (CVC)
Comparison with monotherapy and different combination doses
Other Name: CVC |
Experimental: Arm C: Tropifexor (LJN452) Dose 1 + CVC
tropifexor 140 mcg + CVC 150 mg, once daily; given orally
|
Drug: Tropifexor (LJN452)
Comparison with monotherapy and different combination doses
Other Name: LJN452 Drug: Cenicriviroc (CVC) Comparison with monotherapy and different combination doses
Other Name: CVC |
Experimental: Arm D: Tropifexor Dose 2 + CVC
tropifexor 90 mcg + CVC 150 mg, once daily; given orally
|
Drug: Tropifexor (LJN452)
Comparison with monotherapy and different combination doses
Other Name: LJN452 Drug: Cenicriviroc (CVC) Comparison with monotherapy and different combination doses
Other Name: CVC |
- Number of Participants With Adverse Events [ Time Frame: AEs were collected from first dose of study treatment until end of study treatment at week 48 and then up to maximum duration of 66 weeks ]
Occurrence of adverse events and serious adverse events
Adverse Events (AEs) are any untoward sign or symptom that occurs during the study treatment and then up to 66 weeks
- Proportion of Participants Who Have at Least a One Point Improvement in Fibrosis [ Time Frame: baseline to 48 Weeks ]Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy
- Proportion of Participants With Resolution of Steatohepatitis [ Time Frame: baseline to 48 weeks ]Efficacy of tropifexor + CVC in patients with Nonalcoholic steatohepatitis (NASH) with fibrosis stage F2/F3 as assessed by histological improvement after 48 weeks of treatment compared to monotherapies (tropifexor and CVC) compared to baseline biopsy

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Written informed consent Male and female patients 18 years or older (at the time of the screening visit). Patients must weigh at least 50 kg (110 lb) and no more than 200 kg (440 lb) to participate in the study.
Able to communicate well with the investigator, to understand and comply with the requirements of the study.
Adequate liver biopsy sample for evaluation by Central Reader. Presence of NASH as demonstrated by histologic evidence based on liver biopsy - NASH with fibrosis stage F2/F3, demonstrated on liver biopsy during the screening period. Alternatively, a historical biopsy can be used if performed within 6 months prior to screening.
Exclusion Criteria:
Use of other investigational drugs within 5 half-lives of enrollment or within 30 days whichever is longer.
History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
Previous exposure to elafibranor, CVC, tropifexor, obeticholic acid (OCA), LMB763 or other FXR agonist.
Participated in a clinical trial and treated with any investigational product being evaluated for the treatment of liver fibrosis or NASH in the 6 months before screening.
Patients taking medications prohibited by the protocol. History of treated or untreated malignancy of any organ system, other than localized basal cell carcinoma of the skin or treated cervical intraepithelial neoplasia, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases .
Pregnant or nursing (lactating) women. Women of child-bearing potential. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more than 20 g/day in females and more than 30 g/day in males, on average) and/or a score on the modified AUDIT questionnaire ≥ 8.
Inability to reliably quantify alcohol consumption. History or evidence of ongoing drug abuse, within the last 6 months prior to randomization.
Prior or planned (during the study) bariatric surgery. Uncontrolled diabetes defined as HbA1c ≥ 9% at screening Clinical evidence of hepatic decompensation or severe liver impairment. Previous diagnosis of other forms of chronic liver disease. Calculated eGFR less than 60 mL/min (using the MDRD formula). History of biliary diversion History of liver transplantation or planned liver transplant. Known positivity for HIV. History or current diagnosis of ECG abnormalities indicating significant risk of safety for the patient to participate.
History of inflammatory bowel disease. Patients who are not candidates for liver biopsy. Presence of cirrhosis on liver biopsy (F4 by NASH CRN System) or medical history Patients with an abnormal platelet count (referring to reference ranges from the central lab).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03517540

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Documents provided by Novartis ( Novartis Pharmaceuticals ):
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03517540 |
Other Study ID Numbers: |
CLJC242A2201J 2017-004208-24 ( EudraCT Number ) LJC242A2201J ( Other Identifier: Novartis ) |
First Posted: | May 7, 2018 Key Record Dates |
Results First Posted: | November 12, 2021 |
Last Update Posted: | April 29, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Steatohepatitis NASH NAFLD |
Fatty Liver Disease Liver Liver fibrosis |
Fatty Liver Liver Cirrhosis Non-alcoholic Fatty Liver Disease Fibrosis Pathologic Processes Liver Diseases Digestive System Diseases |
Cenicriviroc CCR5 Receptor Antagonists Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents |