NCT02686762

Emricasan, a Caspase Inhibitor, for Evaluation in Subjects With Non-Alcoholic Steatohepatitis (NASH) Fibrosis

A Multicenter, Randomized, Double-Blind, Placebo-controlled Trial of Emricasan (IDN-6556-12), an Oral Caspase Inhibitor, in Subjects With Non-alcoholic Steatohepatitis (NASH) Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (actual)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, double-blind, randomized, placebo-controlled trial involving subjects with a diagnosis of "definite NASH" with fibrosis (excluding cirrhosis) as determined by the central histopathologist. Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID or emricasan 5 mg BID or matching placebo BID.

Conditions

• Non-alcoholic Steatohepatitis
• Fibrosis
• Liver Diseases

Interventions

Type	Name	Description
DRUG	Emricasan (5 mg)	Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (5 mg) twice a day.
DRUG	Emricasan (50 mg)	Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (50 mg) twice a day.
DRUG	Placebo	Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with a matching placebo twice a day.

Timeline

• Start date: 2016-01-26
• Primary completion: 2019-01-29
• Completion: 2019-02-28
• First posted: 2016-02-19
• Last updated: 2019-08-19

Locations

103 sites across 3 countries: United States, Germany, Spain