A Phase 2B, Randomized, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rencofilstat in Adult Subjects With Nonalcoholic Steatohepatitis and Advanced Liver Fibrosis
Overview
- Phase
- Phase 2
- Intervention
- Rencofilstat
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Sponsor
- Hepion Pharmaceuticals, Inc.
- Enrollment
- 120
- Locations
- 37
- Primary Endpoint
- Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis.
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cohort B: Rencofilstat 150 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 150 mg daily.
Intervention: Rencofilstat
Cohort A: Rencofilstat 75 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 75 mg daily.
Intervention: Rencofilstat
Cohort C: Rencofilstat 225 mg
Eighty-four (84) biopsy-proven NASH F2/F3 subjects to complete study on Rencofilstat 225 mg daily.
Intervention: Rencofilstat
Cohort D: Placebo
Eighty-four (84) biopsy-proven NASH F2 / F3 subjects to complete study on matching placebo.
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of subjects with improvement in fibrosis by at least 1 stage (NASH CRN system) OR NASH resolution without worsening of fibrosis.
Time Frame: dosing period of 1 year with 1 month observation and follow up period
Efficacy
Secondary Outcomes
- 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)
- 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)
- 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)
- Change from baseline in Pro-C3, type III collagen neo-epitopes.(dosing period of 1 year with 1 month observation and follow up period)
- Change from baseline in ALT.(dosing period of 1 year with 1 month observation and follow up period)
- Change from baseline in AST.(dosing period of 1 year with 1 month observation and follow up period)