CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 53 enrolled
Drug / intervention
Idebenone +1 moredrug
Likely dose
Idebenone 200mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04669158
NCT04669158Phase 2Completed
CompareCT.gov

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

Stanford University·interventional·Posted Dec 16, 2020·Updated Apr 24, 2026

In Brief

A Phase 2 clinical trial evaluating Idebenone and Placebo for Non Alcoholic Steatohepatitis and Fibrosis. Completed, enrolled 53 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon Alcoholic Steatohepatitis, Fibrosis
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 16, 2020
Enrollment StartJul 30, 2021
Primary CompletionJul 5, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.5 years ago

Interventions

Idebenonedrug

Idebenone, initially 200mg by mouth (P.O.) once a day for 2 weeks, then 200 mg twice a day for 2 weeks, then 200 mg three times per day for the remainder of the study will be used.

Placebodrug

Placebo to match Idebenone once a day for 2 weeks, then twice a day for 2 weeks, then three times per day for the remainder of the study will be used.