NCT04480710

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Hepion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• NASH - Nonalcoholic Steatohepatitis
• Fibrosis, Liver
• NAFLD - Nonalcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	CRV431 75mg	1 x 75mg softgel capsule
DRUG	Placebo (1 softgel)	1 x placebo softgel capsule
DRUG	CRV431 225mg	3 x 75mg softgel capsule
DRUG	Placebo (3 softgels)	3 x placebo softgel capsule

Timeline

• Start date: 2020-06-23
• Primary completion: 2021-06-29
• Completion: 2021-10-30
• First posted: 2020-07-21
• Last updated: 2022-07-15
• Results posted: 2022-07-15

Locations

10 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study