Actively Recruiting
Digoxin In NASH (CODIN)
Led by Yale University · Updated on 2025-10-31
144
Participants Needed
2
Research Sites
186 weeks
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) 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.
CONDITIONS
Official Title
Digoxin In NASH (CODIN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Stable body weight (5% or less change) in the 30 days before screening
- Biopsy-confirmed nonalcoholic steatohepatitis (NASH) with a NAS score of 4 or higher and at least 1 in steatosis, hepatocellular ballooning, and lobular inflammation on biopsy within 6 months
- Liver fibrosis stage 2 or 3 confirmed by biopsy within 6 months before screening
- Agreement to have liver biopsies at baseline if none done within 6 months and 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, HIV, or hepatitis C
- AST or ALT levels more than 5 times the upper limit of normal at screening
- Total bilirubin over 1.5 mg/dL unless conjugated bilirubin is less than 1.5 times upper limit
- INR greater than 1.3 at screening
- Alcohol use over 20 g/day for women or over 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 anticipated use of medications affecting steatosis within 30 days
- Heart rate under 60 bpm at screening or baseline
- Severe aortic valve disease, history of accessory AV pathway, certain heart blocks without device, permanent atrial fibrillation
- Recent serious cardiac events or surgeries within 6 months
- Current use of specific cardiac, neuromuscular, calcium, or other listed medications
- Recent initiation (within 30 days) of weight loss medications or participation in diet-based weight programs
- Recent obesity surgery within 6 months
- History of cancer in past 5 years except certain skin cancers or carcinoma in-situ
- Planned surgery during study except minor procedures
- Language barriers or inability to comply with study
- Known allergy to study product or related substances
- Recent participation in other clinical trials within 90 days
- Female participants who are pregnant, breastfeeding, or not using contraception if of childbearing potential
- Kidney function with eGFR less than 30 ml/min/1.73 m2
- Abnormal thyroid hormone levels (TSH outside 0.4-6 mIU/L)
- Claustrophobia or metal implants preventing MRI examination
AI-Screening
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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
Research Team
B
Bubu Banini, MD, PhD
CONTACT
T
Tara McPartland
CONTACT
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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