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Could a common supplement help fatty liver disease?

NCT ID NCT04669158

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested an oral drug called idebenone in 53 adults with non-alcoholic steatohepatitis (NASH) and mild-to-moderate liver scarring. The main goal was to check safety and tolerability, while also looking for signs that the drug might reduce liver stiffness and scarring. Participants received either idebenone or a placebo for a set period, and researchers monitored side effects and changes in liver health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

53 people

The number who actually took part.

Started

Jul 2021

Finished

Jul 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1\) Male or non-pregnant/ non-lactating women ≥ 18 years of age * 2\) Diagnosis of NASH: NAFLD activity score (NAS) of 4 or greater with a score of 1 for each of the following (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2): * Steatosis * Lobular inflammation * Hepatocyte ballooning 3) Fibrosis (Ishak fibrosis score ≥1 on liver biopsy) within 6 months of enrollment with MELD\<10, or based on MRE Exclusion Criteria: * Presence of any other form of liver disease, including viral hepatitis, autoimmune hepatitis, alcoholic liver disease, genetic causes of chronic liver disease): * Subjects with other etiologies of chronic liver disease, such as chronic hepatitis B and C; autoimmune hepatitis; and inherited liver disease. * ALT\>300 U/l * Total serum bilirubin ≥ to 1.3 mg/dL (Gilbert's Syndrome patients excepted) * International Normalized Ratio (INR) ≥ 1.3 * MELD\>10 * Serum creatinine \>2.0mg/dl * Known alcohol abuse or alcohol use disorder: * \>20 g/day for women * \>30 g/day for men * Active substance abuse * Any medical condition that prevents MRE, MR-PDFF * Platelet count ≤100//mm3 * Decompensated cirrhosis * Hemoglobin \<11 g/dl in females or \<12 g/dl in males * Presence/history of HCC * History of liver transplantation * History of bariatric surgery * History of inflammatory bowel disease * History of cardiovascular disease, long QT syndrome. * Subjects who have participated in investigational drug trials and took any investigational drugs within 60 days prior to the first dose of Idebenone. History of receiving other investigations drug within 30 days prior to enrollment * Any concerns regarding compliance by enrolling physician

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Conditions

The condition(s) this trial relates to.

Fibrosis fibrotic liver disease metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibrosis Non - alcoholic steatohepatitis

Contacts and locations

Locations

  • Digestive Health Center, Stanford University

    Redwood City, California, 94063, United States

  • Stanford University

    Stanford, California, 94305, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.