A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis
- Conditions
- Nonalcoholic Steatohepatitis (NASH)NAFLDFibrosis, Liver
- Interventions
- Drug: Placebo
- Registration Number
- NCT05402371
- Lead Sponsor
- Hepion Pharmaceuticals, Inc.
- Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.
- Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-dosing, multi-center study to evaluate the efficacy and safety of Rencofilstat as evidenced by histopathological improvements in fibrosis in adult NASH subjects with F2 or F3 fibrosis (NASH CRN system). Antifibrotic biomarker activity will be evaluated on an exploratory basis.
This study consists of 3 phases: (i) Screening and Randomization; (ii) treatment; and (iii) follow up. During Screening, each subject will provide informed consent prior to starting any study specific procedures. The randomization of the F2/F3 NASH subjects will be performed in a 1:1:1:1 ratio between Rencofilstat 75mg, Rencofilstat 150mg, Rencofilstat 225mg, and matching placebo. Subjects will be stratified by presence or absence of Type 2 diabetes, fibrosis stage and a maximum of 34 F2 subjects in each cohort.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort C: Rencofilstat 225 mg Rencofilstat Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 225 mg daily. Cohort D: Placebo Placebo Eighty-four (84) biopsy-proven NASH F2 / F3 subjects to complete study on matching placebo. Cohort A: Rencofilstat 75 mg Rencofilstat Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 75 mg daily. Cohort B: Rencofilstat 150 mg Rencofilstat Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 150 mg daily.
- Primary Outcome Measures
Name Time Method Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis. dosing period of 1 year with 1 month observation and follow up period Efficacy
- Secondary Outcome Measures
Name Time Method Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system), regardless of effect on NASH. dosing period of 1 year with 1 month observation and follow up period Efficacy
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system), regardless of effect on NASH. dosing period of 1 year with 1 month observation and follow up period Efficacy
Proportion of subjects with improvement in fibrosis by at least 2 stages (NASH CRN system) AND no worsening of NASH. dosing period of 1 year with 1 month observation and follow up period Efficacy
Change from baseline in Pro-C3, type III collagen neo-epitopes. dosing period of 1 year with 1 month observation and follow up period Efficacy
Change from baseline in ALT. dosing period of 1 year with 1 month observation and follow up period Efficacy
Change from baseline in AST. dosing period of 1 year with 1 month observation and follow up period Efficacy
Trial Locations
- Locations (37)
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Arizona Liver Health-Chandler
🇺🇸Chandler, Arizona, United States
Arizona Liver Health
🇺🇸Peoria, Arizona, United States
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Arizona Liver Health-Tuscon
🇺🇸Tucson, Arizona, United States
Preferred Research Partners, Inc.
🇺🇸Little Rock, Arkansas, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
National Research Institute
🇺🇸Santa Ana, California, United States
Synergy Healthcare, LLC
🇺🇸Bradenton, Florida, United States
Tampa Bay Medical Research, Inc.
🇺🇸Clearwater, Florida, United States
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