Oral Idebenone for Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byNatalie Torok, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Stanford University

Trial Summary

What is the purpose of this trial?

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.

Research Team

Natalie Torok, MD

Principal Investigator

Stanford University

Eligibility Criteria

Adults over 18 with non-alcoholic steatohepatitis (NASH) and moderate liver fibrosis can join this study. They must have a specific level of fat, inflammation, and cell damage in the liver but not severe liver dysfunction or other serious health issues like heart disease or recent drug trial participation.

Inclusion Criteria

I have been diagnosed with NASH with a specific severity score.

My liver has some scarring but my overall liver function is still good.

I am an adult over 18 and not pregnant or breastfeeding.

Exclusion Criteria

I have had a liver transplant.

My liver is severely damaged and cannot function properly.

My hemoglobin level is below the normal range for my gender.

See 17 more

Treatment Details

Interventions

Idebenone (Antioxidant)

Trial OverviewThe trial is testing Idebenone, an oral medication, against a placebo to see if it's safe and can improve liver health in NASH patients. Participants are randomly chosen to receive either the real drug or a fake pill without knowing which one they get.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IdebenoneExperimental Treatment1 Intervention

Participants will take Idebenone 200 mg for 48 weeks, with study visits in clinic for physical and laboratory assessments at weeks 0, 2, 4, 12, 24, 36, and 48 weeks during treatment period and at 4, and 12 weeks after the last dose.

Group II: PlaceboPlacebo Group1 Intervention

Participants will take Placebo for 48 weeks, with study visits in clinic for physical and laboratory assessments at weeks 0, 2, 4, 12, 24, 36, and 48 weeks during treatment period and at 4, and 12 weeks after the last dose.