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COMPLETED
NCT04669158
PHASE1/PHASE2

Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

53

Start Date

2021-07-30

Completion Date

2023-07-05

Last Updated

2026-04-24

Healthy Volunteers

No

Interventions

DRUG

Idebenone

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.

DRUG

Placebo

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.

Locations (2)

Digestive Health Center, Stanford University

Redwood City, California, United States

Stanford University

Stanford, California, United States