New uses for an old remedy: Digoxin as a potential treatment for steatohepatitis and other disorders.
Fatima Jamshed, Farzaneh Dashti, Xinshou Ouyang...
https://pubmed.ncbi.nlm.nih.gov/37032732Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID06588699
Clinical Trial of Oral Digoxin in Nonalcoholic Steatohepatitis (NASH) (CODIN)
Led by Yale University · Updated on 2026-05-26
144
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Nonalcoholic steatohepatitis (NASH), also called metabolic associated steatohepatitis (MASH), is a serious form of nonalcoholic fatty liver disease affecting many people. This condition often leads to liver fibrosis, which is a key factor in disease progression and mortality. Researchers are exploring the use of digoxin, a drug currently used for heart conditions, to see if it can benefit patients with NASH by improving liver health and reducing fibrosis. The trial is a prospective, randomized, double-blind, placebo-controlled study comparing two oral digoxin dosing methods given once daily—titration-based dosing using weight and kidney function, and weight-based dosing at 0.15 mcg/kg/day—against a placebo. Participants will receive these treatments to evaluate their effects on NASH resolution and liver fibrosis over 24 weeks. Participants will undergo liver biopsies before treatment and at 24 weeks to assess liver tissue changes. Researchers will also monitor liver enzymes, imaging markers like MRI and elastography, and biochemical scores to track liver health. The study includes safety and tolerability assessments, with follow-up visits to measure treatment impact and any side effects during the trial period.
CONDITIONS
Brief Title
Digoxin In NASH (CODIN)
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Stable body weight with less than or equal to 5% change in the 30 days before screening
- Biopsy-confirmed nonalcoholic steatohepatitis (NASH) with NAS score 4 or higher and at least 1 in steatosis, ballooning, and inflammation on biopsy within 6 months
- Liver fibrosis stage 2 or 3 confirmed by biopsy within 6 months before screening
- Agreement to have a liver biopsy at baseline if none done within 6 months and again at 24 weeks after randomization
You will not qualify if you...
- Other chronic liver diseases besides NASH
- History or signs of cirrhosis or portal hypertension
- Positive tests for hepatitis B surface antigen, HIV, or hepatitis C virus RNA
- AST or ALT levels more than 5 times the upper normal limit at screening
- Total bilirubin over 1.5 mg/dL unless conjugated bilirubin is less than 1.5 times upper limit
- International normalized ratio (INR) above 1.3 at screening
- Alcohol use exceeding 20 g/day for women or 30 g/day for men
- Recent start or dose change within 30 days of vitamin E, pioglitazone, GLP-1 receptor agonists, or SGLT-2 inhibitors
- Recent or planned use of medications affecting liver fat (like corticosteroids, tamoxifen, valproic acid) within 30 days
- Heart rate below 60 bpm or severe heart conditions such as aortic valve disease, heart blocks without pacemaker, permanent atrial fibrillation
- Recent serious cardiac events or surgeries within 6 months
- Current use of certain cardiac or other specified medications
- Recent use of weight loss medications or participation in weight loss programs within 30 days
- Recent obesity surgery within 6 months
- History of cancer in past 5 years except certain skin cancers
- Scheduled surgery during trial except minor procedures
- Language or mental incapacity to comply with study
- Allergies to milk, egg, soy, peanuts, sulfites, or trial product
- Recent participation in other clinical trials within 90 days
- Pregnancy, breastfeeding, or inadequate contraception in women of childbearing potential
- Severe kidney impairment (eGFR below 30 ml/min/1.73 m2)
- Abnormal thyroid hormone levels at screening
- Claustrophobia or metal implants preventing MRI examination
- Use of calcium supplements, parathyroid hormone analog, neuromuscular blockers, or disulfiram during screening or baseline visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - 24 weeks
Participants take oral digoxin or matched placebo once daily to evaluate effects on nonalcoholic steatohepatitis (NASH).
Trial Site Locations
Total: 2 locations
1
Yale New Haven Health
New Haven, Connecticut, United States, 06510
Actively Recruiting
2
Yale New Haven Hospital
New Haven, Connecticut, United States, 06510
Actively Recruiting
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Research Team
B
Bubu Banini, MD, PhD
T
Tara McPartland
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Digoxin as an emerging therapy in noncardiac diseases.
Farzaneh Dashti, Fatima Jamshed, Xinshou Ouyang...
https://pubmed.ncbi.nlm.nih.gov/36396496Nonalcoholic liver disease: Epidemiology, risk factors, natural history, and management strategies.
George Agyapong, Farzaneh Dashti, Bubu A Banini
https://pubmed.ncbi.nlm.nih.gov/37400359Screening, Diagnosis, and Staging of Non-Alcoholic Fatty Liver Disease (NAFLD): Application of Society Guidelines to Clinical Practice.
Ysabel C Ilagan-Ying, Bubu A Banini, Albert Do...
https://pubmed.ncbi.nlm.nih.gov/37768417