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Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
Sponsor: Stanford University
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
Conditions
Interventions
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.
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