Digoxin for Fatty Liver Disease
(CODIN Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byBubu A Banini, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Yale University

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

Nonalcoholic steatohepatitis (NASH) is a severe subtype of nonalcoholic fatty liver disease (NAFLD) which affects 1 in 3 Americans. The mainstay of treatment for NASH, which was recently renamed metabolic associated steatohepatitis (MASH), involves lifestyle interventions to promote weight loss and to treat comorbidities such as hypertension, hyperlipidemia, and diabetes mellitus. There is thus, a substantial unmet need for pharmacological therapies that are effective for treatment of NASH, especially in those with fibrosis which is the main predictor of disease progression and mortality among NASH patients. The repurposing of presently available drugs would help expedite the search for agents effective in treating NASH. The cardiac glycoside digoxin is currently used in the management of heart failure and supraventricular tachyarrhythmias. The investigators and other groups have demonstrated that digoxin protects the liver from various forms of acute and chronic liver injury. The investigators preliminary data in healthy human subject indicate an immunomodulatory effect of low dose oral digoxin with no adverse side effects. This study proposes to demonstrate the clinical benefits of digoxin on NASH and on liver fibrosis, thus supporting the repurposing of digoxin as treatment for NASH.

Research Team

Bubu A Banini, MD, PhD

Principal Investigator

Yale University

Eligibility Criteria

This trial is for individuals with a severe type of fatty liver disease called NASH, which can lead to fibrosis and cirrhosis. Participants should be looking for new treatments beyond lifestyle changes and management of related conditions like high blood pressure or diabetes.

Inclusion Criteria

My liver biopsy shows moderate to severe scarring.

My liver biopsy confirms I have NASH with a NAS score of 4 or higher.

I agree to a liver biopsy if I haven't had one in the last 6 months and another at 24 weeks after starting the trial.

See 1 more

Exclusion Criteria

I have a history of cirrhosis or signs of high blood pressure in the liver.

I haven't started or changed doses of certain diabetes or vitamin E medications in the last 30 days.

I understand and can follow the study's procedures.

See 27 more

Treatment Details

Interventions

Digoxin (Other)

Trial OverviewThe CODIN trial is testing whether the heart medication digoxin can help treat NASH by protecting the liver and reducing fibrosis. Patients will either receive digoxin or a placebo (a pill without any active drug) to compare effects.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Digoxin (weight-based)Experimental Treatment1 Intervention

Digoxin (weight-based) taken orally once daily. In the weight-based digoxin arm, the intervention will be oral digoxin 0.15mcg/kg/day.

Group II: Digoxin (titration-based)Experimental Treatment1 Intervention

Digoxin (titration-based) taken orally once daily. In this arm, the intervention will be administered dosed by weight and renal function using a well-studied digoxin nomogram.

Group III: PlaceboPlacebo Group1 Intervention

Placebo, taken orally once daily

Digoxin is already approved in Canada, Japan for the following indications: