Digoxin In NASH (CODIN)

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT06588699
Phase
PHASE2
Status
Recruiting
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Conditions

  • Fatty Liver Disease
  • Fatty Liver Disease, Nonalcoholic
  • MASH - Metabolic Dysfunction-Associated Steatohepatitis
  • MASH With Fibrosis
  • MASLD
  • Mash
  • NAFLD
  • NASH

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Digoxin — DRUG
    Taken orally once daily
  • Placebo — DRUG
    Matched Placebo taken orally once daily

Study Details

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.

Key Dates

Start date
Jun 5, 2025
Status verified
Mar 2026
Primary completion
Jan 31, 2029
Completion
Jan 31, 2029

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Resolution of nonalcoholic steatohepatitis (NASH) without worsening of fibrosis [ Time Frame: 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Yale New Haven HealthNew HavenConnecticut06510
Bubu Banini, MD
[email protected]
Aida Rodriguez Murillo
[email protected]
Bubu Banini, MD (PRINCIPAL_INVESTIGATOR)
Yale New Haven HospitalNew HavenConnecticut06510
Bubu Banini, MD
[email protected]
Aida Rodriguez Murillo
[email protected]
Bubu Banini, MD (PRINCIPAL_INVESTIGATOR)

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