NCT02077374

A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases

A Placebo-Controlled, Multicenter, Double-Blind, Randomized Trial of IDN-6556 in Subjects With Non-Alcoholic Fatty Liver Disease and Raised Transaminases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Conatus Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests

Detailed description

This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.

Conditions

• Nonalcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	IDN-6556	25 mg BID for 28 days
OTHER	Placebo	Placebo BID for 28 Days

Timeline

• Start date: 2014-03-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-03-04
• Last updated: 2016-08-30
• Results posted: 2016-07-21

Locations

7 sites across 1 country: United States