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NCT06588699 · ClinicalTrials.gov registry record · Phase 2
Digoxin In NASH (CODIN)
A Phase 2 study of NAFLD and NASH, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
- 2
- Study locations
NCT06588699: Recruiting Phase 2 study of NAFLD and NASH, sponsored by Yale University.
NCT06588699 is a Phase 2 study of NAFLD and NASH that is actively recruiting participants, run by Yale University. The registered enrollment target is 144 participants, below the 160-participant average among 26 other NAFLD trials with a reported enrollment target (10% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06588699, a Phase 2 study of NAFLD and NASH, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Proportion of participants who achieve resolution of NASH (defined by the NASH Clinical research network \[CRN\] as a score of 0-1 for inflammation, 0 for hepatocyte ballooning, and any value for steatosis) with no worsening of fibrosis (yes/no).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Digoxin
Study Locations (2)
Connecticut
- Yale New Haven Health - New Haven
- Yale New Haven Hospital - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2025-06-05 |
| Est. Completion | 2029-01 |
| Phase | Phase 2 |
What NCT06588699 shows while recruiting
NCT06588699 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 160-participant average among 26 other NAFLD trials with a reported enrollment target (10% lower).
The record links to 8 conditions, with NAFLD appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06588699 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06588699 about?
NCT06588699 is a clinical study titled "Digoxin In NASH (CODIN)". 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 ...
What is the current status of trial NCT06588699?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2025-06-05. Estimated completion is 2029-01.
What conditions does trial NCT06588699 study?
This clinical trial studies the following conditions: NAFLD, NASH, MASLD, MASH, MASH - Metabolic Dysfunction-Associated Steatohepatitis.
What interventions are being tested in trial NCT06588699?
The interventions under investigation include: Placebo (DRUG), Digoxin (DRUG).
Who is sponsoring clinical trial NCT06588699?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06588699 being conducted?
This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06588699's enrollment target sits among peer trials
144 8th of 26 higher than 19 of 26 other NAFLD trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NAFLD trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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