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New treatment option for NASH
Official title Digoxin In NASH (CODIN)
ClinicalTrials.gov ID: NCT06588699
What this study is testing
What is Digoxin?
Digoxin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for nash.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening
- Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks...
You likely can't join if
- Liver-related:
- 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
See the full eligibility criteria
Who can join
- 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...
- Histological fibrosis stage 2 or 3 based on pathologist evaluation of a liver biopsy performed up to 6 months before screening
- Agrees to have a liver biopsy performed to assess baseline histology if one has not been performed up to 6 months before screening, and at 24 weeks after randomization
What rules you out
- Liver-related:
- 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)...
- 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...
- 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...
- 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 General safety related:
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.