MedTrace Logo

A Study to Evaluate the Safety and Efficacy of Rencofilstat in Adult Subjects With NASH F3

NCT05461105 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-13

No results posted yet for this study

Summary

This is a randomized, open-label, parallel-dosing, multi-center study to evaluate the safety and efficacy of rencofilstat as evidenced by assessing changes in the HepQuant Shunt Disease Severity Index Score (DSI), safety labs, and clinical events in adult NASH subjects with compensated Fibrosis stage F 2/3. Antifibrotic biomarker activity will be evaluated on an exploratory basis.

Conditions

  • NASH With Fibrosis

Interventions

DRUG

rencofilstat, 75 mg

1 softgel capsule

DRUG

rencofilstat, 150mg

2 softgel capsules

DRUG

rencofilstat, 225 mg

3 softgel capsules

Sponsors & Collaborators

  • Hepion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-15
Primary Completion
2023-04-15
Completion
2023-07-07
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05461105 on ClinicalTrials.gov