Trials / Active Not Recruiting

Active Not RecruitingNCT05402371

A Study to Evaluate the Efficacy and Safety of Rencofilstat in Subjects With NASH and Advanced Liver Fibrosis

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

Status: Active Not Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 120 (actual)

Sponsor: Hepion Pharmaceuticals, Inc. · Industry
Sex: All
Age: 18 Years – 75 Years
Healthy volunteers: Not accepted

Summary

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.

Conditions

Interventions

Type	Name	Description
DRUG	Rencofilstat	Rencofilstat soft gel capsule
DRUG	Placebo	placebo soft gel capsule

Timeline

Start date: 2022-10-15
Primary completion: 2025-05-01
Completion: 2025-09-01
First posted: 2022-06-02
Last updated: 2024-05-03

Locations

41 sites across 3 countries: United States, France, Mexico

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05402371. Inclusion in this directory is not an endorsement.