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A Study of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects — AMBITION  

NASH - Nonalcoholic Steatohepatitis Clinical Trial

Official title:
AMBITION: A Phase 2A, Multiple-Center, Single-Blind, Placebo-Controlled Study To Evaluate The Safety and Tolerability of CRV431 Dosed Once Daily in NASH Induced F2 and F3 Subjects

Clinical Trial Summary

This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects.

Clinical Trial Description

This is a randomized, single-blind, placebo-controlled, once daily (QD) dose study of CRV431 in presumed NASH F2/F3 subjects. Study will evaluate the safety and tolerability of a once daily 75mg dose and 225mg of CRV431 compared to placebo over 28 days of dosing. Pharmacokinetic parameters of CRV431 and its major metabolites and fraction unbound will also be evaluated. Non-invasive antifibrotic bio-markers will be collected and quantified from presumed NASH F2/F3 subjects dosed with 75mg CRV431 or placebo. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04480710
Study type Interventional
Source Hepion Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date June 23, 2020
Completion date October 30, 2021
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