NCT06588699

Digoxin In NASH (CODIN)

Clinical Trial of Oral Digoxin In NASH (CODIN)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Prospective, randomized, double-blind, placebo-controlled, single center trial of digoxin in patients with nonalcoholic steatohepatitis (NASH). Primary objective: To compare the effect of digoxin oral, administered once daily (QD) either as titration-based or weight-based dose, versus placebo on histologic resolution of NASH Key secondary objectives: To investigate the effect of digoxin oral, administered once daily (QD) either as titration-based or weight-based dose, compared to placebo on histologic, imaging, and biochemical markers of NASH, and to assess the safety and tolerability of digoxin compared to placebo

Conditions

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

Interventions

Type	Name	Description
DRUG	Digoxin	Taken orally once daily
DRUG	Placebo	Matched Placebo taken orally once daily

Timeline

• Start date: 2025-06-05
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2024-09-19
• Last updated: 2025-10-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study