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Digoxin for NASH (CODIN) Study

This study is looking into whether a medication called digoxin, taken once a day by mouth, can help people with Nonalcoholic Steatohepatitis (NASH), also known as Metabolic Dysfunction-Associated Steatohepatitis (MASH). NASH is a severe type of fatty liver disease. The study aims to see if digoxin can resolve NASH without making liver scarring (fibrosis) worse. You might be able to join if you are 18 to 75 years old, have a stable body weight, and have NASH that has been confirmed by a liver biopsy. The study is currently recruiting about 144 participants, but its exact status is unclear.

Study design
This is a prospective, randomized, double-blind, placebo-controlled study, meaning participants will be randomly assigned to receive either digoxin or a placebo (an inactive substance), and neither you nor your doctor will know which you are receiving. The study plans to enroll 144 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at 24 weeks, which suggests participants will be followed for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06588699

Digoxin In NASH (CODIN)

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Yale University
~144 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:DigoxinPlacebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resolution of nonalcoholic steatohepatitis (NASH) without worsening of fibrosis
Measured over 24 weeks

Conditions

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

Explore related trials

Nonalcoholic Steatohepatitis

NCT06588699

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Yale New Haven Health

    New Haven, Connecticutstudy coordinator listed

    Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticutstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bubu A Banini, MD, PhD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Bubu Banini, MD, PhD
[email protected]
203-737-6063 or 203-215-7749
Email the study team

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Eligibility criteria

Inclusion

Stable body weight (≤ 5% self-reported change in body weight) in the 30 days prior to screening
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
Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening

Exclusion

Documented causes of chronic liver disease other than NASH
History or clinical evidence of cirrhosis or portal hypertension
History of positive HBsAg, positive anti-HIV, positive HCV-RNA
AST or ALT \> 5 times upper limit of normal (ULN) at screening
Total bilirubin \> 1.5 mg/dL at screening unless conjugated bilirubin is \< 1.5 × ULN
International normalized ratio (INR) \> 1.3 at screening
Known or suspected alcohol use \> 20 g/day for women or \> 30 g/day for men
Treatment initiation or dose adjustment of vitamin E, pioglitazone, GLP-1RA, or SGLT-2 inhibitors within 30 days of signing the informed consent or 30 days prior to liver biopsy
Treatment initiation or anticipated treatment (\>14 consecutive days) with medications known to affect steatosis (e.g., systemic corticosteroids, tamoxifen, valproic acid, methotrexate, tetracycline or amiodarone) within 30 days of signing the informed consent or 30 days prior to liver biopsy
Heart rate less than 60 bpm at screening (visit 1) or at baseline (visit 2)
Current diagnosis of severe aortic valve disease
History of Accessory arterio-ventricular pathway (e.g., Wolf-Parkinson-White syndrome)
History of complete heart block or second degree arterio-ventricular block without pacemaker or implantable cardiac device
Current diagnosis of permanent atrial fibrillation
Any of the following within the previous 6 months of signing informed consent: myocardial infarction, percutaneous intervention, pacemaker/implantable cardiac device implantation, cardiac surgery, or stroke
Current use of the following medications: inotropic drugs such as (dopamine, dobutamine, noradrenaline, milrinone), anti-arrhythmics (amiodarone, dofetilide, sotalol, dronedarone, digoxin), parathyroid hormone analog (teriparatide), sympathomimetics (epinephrine, norepinephrine, dopamine), neuromuscular blocking agents (succinylcholine), calcium supplement, nondihydropyridine calcium channel blockers, ivabradine, and disulfiram.
Treatment initiation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) with orlistat, zonisamide, topiramate, phentermine, bupropion, and naltrexone alone or in combination or any other medication that could promote weight loss in the opinion of the investigator
Participation (in the 30 days prior to signing the informed consent or 30 days prior to liver biopsy) in an organized diet-based weight reduction program (e.g., WeightWatchers, Optifast)
Recent surgical treatment (\<6 months of signing informed consent) for obesity
Presence or history of malignant neoplasms (in the past 5 years prior to screening), except basal and squamous cell skin cancer and any carcinoma in-situ
Surgery scheduled or anticipated during the trial period, except for minor surgical procedures, in the opinion of the investigator
Language barrier, mental incapacity, unwillingness, or inability to adequately understand or comply with study procedures
Known or suspected hypersensitivity to the trial product or related products including allergy to milk, egg, soy, peanuts, and sulfites
Recent participation (within 90 days prior to signing the informed consent) in any clinical trial of an approved or non-approved investigational medicinal product
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR \< 30 ml/min/1.73 m2
TSH \> 6 mIU/L or \< 0.4 mIU/L at screening
Current use of the following medications: calcium supplementation, parathyroid hormone analog (teriparatide), neuromuscular blocking agents (succinylcholine) and disulfiram.
Claustrophobia to an extent that would prevent tolerance of MRI
Metallic implant that would prevent MRI examination including, metallic foreign body, aneurysm clips, vascular grafts or cardiac implants, neural stimulator, cochlear implant, metallic contraceptive device, body piercing that cannot be removed, cochlear implant, or any other contraindication to MRI

What this trial measures

  • Resolution of nonalcoholic steatohepatitis (NASH) without worsening of fibrosis24 weeks

    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).