Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis

Non Alcoholic Steatohepatitis Clinical Trial

Official title: A Pilot Study to Treat Adults With Non-Alcoholic Steatohepatitis With Oral Idebenone

Status Active, not recruiting

Clinical Trial Summary

This is a randomized, placebo-controlled phase 1/2a study to investigate the safety and tolerability of Idebenone in patients 18 years of age or older with non-alcoholic steatohepatitis, with stage 1-3 fibrosis. As secondary end point target engagement and fibrosis improvement will be assessed.

Clinical Trial Description

This is a prospective phase 1/2a, randomized, double-blinded, placebo-controlled, single center study of safety and efficacy of oral idebenone in adults 18 years of age or older with non-alcoholic steatohepatitis (NASH). Following IRB approval and written informed consent, 45 participants will be enrolled in the study and randomized in a 1:2 ratio on REDCap data capturing software. Participants will be randomized to two groups and receive the following tablets: placebo, idebenone at escalating doses of 200mg by mouth (P.O.) once a day for 2 weeks, then 200 mg twice a day for 2 weeks, then 3 times per day for the remainder of the study (up to 48 weeks). Monitoring and safety evaluation will continue for 12 weeks after the final dose. The study will investigate the safety and tolerability as primary end point and assess target engagement and fibrosis improvement as secondary end points. ;

Related Conditions & MeSH terms

• Fatty Liver
• Non Alcoholic Steatohepatitis
• Non-alcoholic Fatty Liver Disease

• NCT number: NCT04669158
• Study type: Interventional
• Source: Stanford University
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: July 30, 2021
• Completion date: September 2024