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Digoxin for Fatty Liver Disease (CODIN Trial)

Phase 2

Waitlist Available

Led By Bubu A Banini, MD, PhD

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-confirmed non-alcoholic steatohepatitis (NASH) as defined by the NASH clinical research network (NASH CRN) histological scoring system, with non-alcoholic fatty liver disease score (NAS) ≥4 and with a score ≥1 for each of the three components (steatosis, hepatocellular ballooning, and lobular inflammation) on a liver biopsy performed within 6 months of screening

Be older than 18 years old

Must not have

History or clinical evidence of cirrhosis or portal hypertension

Liver-related: Documented causes of chronic liver disease other than NASH

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Summary

"This trial aims to find a new treatment for a liver condition called NASH, which affects many Americans. Current treatment involves lifestyle changes like weight loss and managing other health conditions. There is a need for

Who is the study for?

This trial is for individuals with a severe type of fatty liver disease called NASH, which can lead to fibrosis and cirrhosis. Participants should be looking for new treatments beyond lifestyle changes and management of related conditions like high blood pressure or diabetes.

What is being tested?

The CODIN trial is testing whether the heart medication digoxin can help treat NASH by protecting the liver and reducing fibrosis. Patients will either receive digoxin or a placebo (a pill without any active drug) to compare effects.

What are the potential side effects?

While low doses of oral digoxin have shown no adverse side effects in preliminary studies, potential side effects may include nausea, dizziness, irregular heartbeat, and other symptoms associated with its use in heart conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver biopsy confirms I have NASH with a NAS score of 4 or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of cirrhosis or signs of high blood pressure in the liver.

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My chronic liver disease is not due to NASH.

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My heart rate was below 60 bpm at my first or second visit.

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I have a history of serious heart rhythm problems without a pacemaker.

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I understand and can follow the study's procedures.

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I have been diagnosed with severe aortic valve disease.

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I haven't had cancer, except for skin cancer or early-stage cancer, in the last 5 years.

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I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.

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I consume less than the daily alcohol limit.

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I haven't taken drugs that affect liver fat for 30 days before signing consent or a liver biopsy.

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I have a history of an extra electrical pathway in my heart (like Wolf-Parkinson-White syndrome).

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I have been diagnosed with permanent atrial fibrillation.

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I am currently taking heart or muscle-related medications, calcium supplements, or disulfiram.

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My kidney function is severely reduced.

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I am currently taking calcium supplements, teriparatide, succinylcholine, or disulfiram.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Resolution of nonalcoholic steatohepatitis (NASH) without worsening of fibrosis

Secondary study objectives

Change in Magnetic resonance elastography (MRE)

Change in alanine aminotransferase (ALT)

Change in aspartate aminotransferase (AST)

+6 more

Side effects data

From 2018 Phase 4 trial • 178 Patients • NCT03136068

hemmorhage

pregnancy labor

fever

cramping

severe nausea

vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Digoxin

Placebo

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Digoxin (weight-based)Experimental Treatment1 Intervention

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

Group II: Digoxin (titration-based)Experimental Treatment1 Intervention

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.

Group III: PlaceboPlacebo Group1 Intervention

Placebo, taken orally once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Digoxin

2017

Completed Phase 4

~670

0 / 16Eligibility criteria met