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Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03823703
Recruitment Status : Terminated (Suspended by sponsor, pending investigation of abnormal laboratory values in patients with NASH)
First Posted : January 30, 2019
Results First Posted : August 31, 2022
Last Update Posted : August 31, 2022
Sponsor:
Information provided by (Responsible Party):
Corcept Therapeutics

Brief Summary:
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).

Condition or disease Intervention/treatment Phase
Nonalcoholic Steatohepatitis (NASH) Drug: Miricorilant Drug: Placebo Phase 2

Detailed Description:

This is a randomized, double-blind, placebo-controlled study that assessed the safety efficacy and pharmacokinetics (PK) of miricorilant in patients with presumed Nonalcoholic Steatohepatitis (NASH). Patients who meet the criteria for Study CORT118335-860 were randomized on Day 1 to receive 900 mg miricorilant, 600 mg miricorilant, or placebo for 12 weeks.

Due to observations related to safety, the study was terminated prior to completion and study objectives, endpoints, and procedures were modified as specified in the protocol.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)
Actual Study Start Date : November 4, 2020
Actual Primary Completion Date : April 5, 2021
Actual Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Miricorilant- 900 mg
Participants received 900 mg miricorilant (6 miricorilant tablets of 150 mg) orally once daily.
Drug: Miricorilant
Tablets taken orally
Other Name: CORT118335

Experimental: Miricorilant- 600 mg
Participants received 600 mg miricorilant (4 miricorilant tablets of 150 mg and 2 placebo tablets) orally once daily.
Drug: Miricorilant
Tablets taken orally
Other Name: CORT118335

Drug: Placebo
Placebo tablets

Placebo Comparator: Placebo
Participants received 6 placebo tablets orally once daily.
Drug: Placebo
Placebo tablets




Primary Outcome Measures :
  1. Relative Change From Baseline in Liver Fat Content Assessed by Magnetic Resonance Imaging-Proton Density Fat Fraction [ Time Frame: Baseline and up to ~Day 95 ]
    The change from baseline in liver fat content (LFC) by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) for each miricorilant dose level (600 mg, 900 mg) versus placebo was assessed. MRI-PDFF was performed to determine the degree of LFC reduction. The relative change is defined for each participant as %: ([Post-Baseline LFC-Baseline LFC]/Baseline LFC) × 100. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.


Secondary Outcome Measures :
  1. Number of Participants Achieving a Relative Reduction From Baseline in LFC of ≥30% by MRI-PDFF [ Time Frame: Baseline and up to ~Day 95 ]
    The number of participants (defined as responders) with a ≥30% reduction in LFC from baseline by treatment group as assessed by MRI-PDFF. The number of participants with a reduction in LFC from baseline of <30% were defined as non-responders. MRI-PDFF was performed at screening and up to 33 days after last dose of study drug. Due to observations related to safety, the study was terminated. If the participant had at least 6 weeks of treatment, the assessment was completed at the early termination visit. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.

  2. Change From Baseline in Aspartate Aminotransferase [ Time Frame: Baseline and Week 6 ]
    The change in aspartate aminotransferase (AST) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.

  3. Change From Baseline in Alanine Aminotransferase [ Time Frame: Baseline and Week 6 ]
    The change in serum alanine aminotransferase (ALT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.

  4. Change From Baseline in Gamma-glutamyl Transferase [ Time Frame: Baseline and Week 6 ]
    The change in gamma-glutamyl transferase (GGT) from baseline for each treatment group at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.

  5. Change From Baseline in Propeptide of Type III Collagen [ Time Frame: Baseline and Week 6 ]
    The change in serum propeptide of Type III collagen (pro-C3) from baseline at the Week 6 visit is summarized. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.

  6. Change From Baseline in Enhanced Liver Fibrosis Score [ Time Frame: Baseline and Week 6 ]
    The change in enhanced liver fibrosis (ELF) from baseline for each treatment group at the Week 6 visit is summarized. The ELF score combines 3 serum biomarkers (hyaluronic acid, tissue inhibitor of metalloproteinases-1 [TIMP-1] and type III procollagen [PIIINP]) which have been shown to correlate with the degree of liver fibrosis assessed by liver biopsy. Each of these markers is measured by an immunoassay and an ELF score is generated [ELF=2.278+0.851 ln(HA)+0.751 ln(PIIINP)+0.394 ln(TIMP-1)], from which a level of fibrosis severity can be determined; higher ELF scores are associated with worsening liver fibrosis. Due to the small sample size, no formal tests were performed to assess statistical differences between treatment groups.


Other Outcome Measures:
  1. Number of Participants With a Relative Reduction in Liver Fat Content ≥50% by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF) for Miricorilant Versus Placebo [ Time Frame: Baseline and up to ~Day 95 ]
  2. Number of Participants With Complete Resolution in Liver Fat by MRI-PDFF for Miricorilant Versus Placebo [ Time Frame: Baseline and up to ~Day 95 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of NASH based on a biopsy obtained within the last year OR
  • Have a diagnosis of presumed NASH based on blood tests and scans

Exclusion Criteria:

  • Have participated in another clinical trial within the last year and received active treatment for NASH
  • Have participated in another clinical trial for any other indication within the last 3 months
  • Are pregnant or lactating women
  • Have a BMI <18 kg/m^2
  • Have had liver transplantation or plan to have liver transplantation during the study
  • Have type 1 diabetes or poorly controlled type 2 diabetes.

Information from the National Library of Medicine

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): NCT03823703


Locations
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United States, Arizona
Site 207
Chandler, Arizona, United States, 85224
Site 208
Glendale, Arizona, United States, 85306
Site 209
Tucson, Arizona, United States, 85712
United States, California
Site 227
Los Angeles, California, United States, 90057
Site 214
Panorama City, California, United States, 91402
Site 233
Santa Ana, California, United States, 92704
United States, Florida
Site 234
Port Orange, Florida, United States, 32127
Site 210
Sarasota, Florida, United States, 34240
United States, Missouri
Site 228
Kansas City, Missouri, United States, 61434
United States, New York
Site 232
East Syracuse, New York, United States, 13057
United States, Texas
Site 211
Austin, Texas, United States, 78757
Site 213
Edinburg, Texas, United States, 78539
Site 215
Edinburg, Texas, United States, 78539
Site 212
San Antonio, Texas, United States, 78229
United States, Washington
Site 226
Seattle, Washington, United States, 98105
Sponsors and Collaborators
Corcept Therapeutics
Investigators
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Study Director: Director Corcept Therapeutics
  Study Documents (Full-Text)

Documents provided by Corcept Therapeutics:
Study Protocol  [PDF] December 7, 2020
Statistical Analysis Plan  [PDF] August 30, 2021

Additional Information:
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Responsible Party: Corcept Therapeutics
ClinicalTrials.gov Identifier: NCT03823703    
Other Study ID Numbers: CORT118335-860
First Posted: January 30, 2019    Key Record Dates
Results First Posted: August 31, 2022
Last Update Posted: August 31, 2022
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Corcept Therapeutics:
Nonalcoholic Steatohepatitis
NASH
Nonalcoholic Fatty Liver Disease
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases