Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People whose body weight has been stable (changed by no more than 5% by their own report) in the 30 days before the screening visit
• People who have a confirmed liver condition called non-alcoholic steatohepatitis (NASH), diagnosed through a liver biopsy taken within 6 months of screening, with specific scoring results showing liver fat, liver cell damage, and inflammation all meeting set thresholds
• People whose liver biopsy (taken within 6 months of screening) shows a mid-level stage of liver scarring (stage 2 or 3 out of 4), as assessed by a specialist
• People who agree to have a liver biopsy done at the start of the trial (if one has not already been done within the past 6 months) and again at 24 weeks after being assigned to a treatment group

Who may not be able to join:

• People who have a chronic liver disease caused by something other than NASH
• People with a history or signs of advanced liver scarring (cirrhosis) or increased pressure in the liver's blood supply (portal hypertension)
• People who have tested positive for hepatitis B, HIV, or hepatitis C
• People whose liver enzyme levels (AST or ALT) are more than 5 times above the normal range at screening
• People with higher-than-allowed bilirubin levels in their blood at screening (confirm with trial site for specific values)
• People with a blood clotting measure (INR) above 1.3 at screening
• People who drink alcohol above a certain daily limit (more than 20 grams per day for women or more than 30 grams per day for men)
• People who have recently started or changed the dose of certain medicines that can affect the liver or body weight — including vitamin E, pioglitazone, GLP-1 receptor agonists, or SGLT-2 inhibitors — within 30 days of signing the consent form or 30 days before the liver biopsy
• People who have recently started, or plan to use for more than 14 days in a row, certain medicines known to affect liver fat (such as steroids, tamoxifen, valproic acid, methotrexate, tetracycline, or amiodarone) within 30 days of signing the consent form or 30 days before the liver biopsy
• People whose heart rate is below 60 beats per minute at the screening or baseline visit
• People currently diagnosed with a severe disease of the aortic heart valve
• People with a history of an abnormal electrical pathway in the heart (such as Wolff-Parkinson-White syndrome)
• People with a history of complete or significant partial heart block who do not have a pacemaker or implanted cardiac device
• People currently diagnosed with permanent atrial fibrillation (an ongoing irregular heart rhythm)
• People who, within the 6 months before signing the consent form, have had a heart attack, a heart procedure (such as a stent), a pacemaker or cardiac device fitted, heart surgery, or a stroke
• People currently taking certain heart or circulation medicines, including specific drugs to support heart function, control heart rhythm, affect calcium levels, or slow the heart rate (confirm full list with trial site)
• People who have recently started (within 30 days of signing the consent form or 30 days before the liver biopsy) certain weight-loss medicines, including orlistat, topiramate, phentermine, bupropion, naltrexone, or similar products
• People who have recently taken part (within 30 days of signing the consent form or 30 days before the liver biopsy) in a structured diet or weight-loss program such as WeightWatchers or Optifast
• People who have had weight-loss surgery within 6 months of signing the consent form
• People with a current or past cancer diagnosis in the last 5 years (excluding certain minor skin cancers and carcinoma in situ)
• People who have planned or anticipated surgery during the trial period, except for minor procedures (as judged by the investigator)
• People who are unable or unwilling to understand or follow the study procedures
• People with a known allergy or sensitivity to the trial product or related ingredients, including allergies to milk, egg, soy, peanuts, or sulfites
• People who have taken part in another clinical trial within 90 days before signing the consent form
• People who are pregnant, breastfeeding, planning to become pregnant, or of childbearing potential and not using an adequate form of contraception
• People with significantly reduced kidney function (eGFR below 30 ml/min/1.73 m²)
• People with thyroid hormone levels (TSH) outside the accepted range at screening (confirm specific values with trial site)
• People currently taking calcium supplements, teriparatide, succinylcholine, or disulfiram
• People with claustrophobia severe enough to prevent them from tolerating an MRI scan
• People with certain metal implants or devices in their body that would make an MRI scan unsafe (confirm full list with trial site)

Important: Always verify eligibility with the trial site directly before applying.