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Phase 2
Age: 18Years - 75Years
All Genders
ID06588699

Study of Oral Digoxin for Treating Nonalcoholic Steatohepatitis NASH and Liver Fibrosis

Led by Yale University · Updated on 2026-05-26

144

Participants Needed

2

Research Sites

N/A

Total Duration

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 dailytitration-based dosing using weight and kidney function, and weight-based dosing at 0.15 mcgkgdayagainst 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)

Research Team

B

Bubu Banini, MD, PhD

T

Tara McPartland

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