NCT04618744

Who might be able to join this trial:

• You are between 18 and 70 years old (male or female).
• Your Body Mass Index (BMI) is 25 or higher (considered overweight or obese).
• You have been diagnosed with type 2 diabetes, confirmed by specific blood sugar tests or by currently taking metformin alone, or metformin plus no more than two other specific diabetes medications (confirm with trial site).
• You have been diagnosed with a liver condition called NAFLD (fatty liver disease), confirmed by specific liver scans showing a certain level of fat in the liver.
• Your liver enzyme levels are mildly to moderately elevated, but not more than 5 times the normal upper limit.
• Your liver scarring (fibrosis) score falls within a specific moderate range, as measured by a special liver scan called FibroScan (confirm with trial site).
• You are willing and able to sign a consent form agreeing to take part.
• If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the trial and agree to use two forms of contraception throughout the study (about 22 weeks).
• If you are a woman who cannot become pregnant (due to menopause or surgical reasons), you meet specific criteria confirming this (confirm with trial site).
• If you have high blood pressure, it must be well controlled on a stable medication dose for at least 2 months before the trial, with blood pressure below 150/95.
• If you have previously taken certain supplements (vitamin E above 400IU/day, certain fish oils, or a liver medication called ursodeoxycholic acid), you must have stopped taking them at least 3 months before joining.
• Your blood sugar control is at an acceptable level, with a HbA1c (average blood sugar) reading of 8.5% or below, and it must not have risen by more than 1% in the 6 months before joining.

Who may not be able to join:

• You have an active liver disease other than NAFLD/NASH, such as viral hepatitis, alcoholic liver disease, or certain inherited liver conditions.
• Your liver enzyme levels are more than 5 times the normal upper limit.
• Your liver is not functioning properly, shown by abnormal results in specific blood tests (confirm with trial site).
• You have had a known problem with alcohol or drug misuse or dependence within the last 5 years.
• You weigh more than 120 kg (approximately 264.6 lbs).
• You have a significant history of heart, digestive, neurological, lung, hormonal, psychiatric, kidney, or cancer-related conditions (other than diabetes).
• You have a condition or history of surgery that could affect how your body absorbs or processes medications, such as inflammatory bowel disease, celiac disease, or certain previous gut surgeries.
• You have lost more than 5% of your body weight in the 6 months before joining.
• You have had weight-loss (bariatric) surgery in the past.
• Your blood pressure is uncontrolled and at or above 150/95.
• You have a type of diabetes other than type 2 (for example, type 1 diabetes).
• You are HIV positive.
• You regularly drink more than 2 units of alcohol per day (if you are a woman) or more than 3 units per day (if you are a man).
• You are taking diabetes medications beyond metformin and more than two other specific diabetes drugs (confirm with trial site).
• You are taking metformin, fibrates, or statins but have not been on a stable dose for the last 6 months.
• You are currently taking certain specific medications including valproic acid, tamoxifen, methotrexate, or amiodarone.
• You are on long-term antibiotic treatment (for example, rifaximin).
• You are currently using homeopathic or alternative treatments (these must be stopped before the screening period).
• You have an uncontrolled thyroid condition (though a well-controlled thyroid condition for at least 6 months may be acceptable — confirm with trial site).
• You have reduced kidney function below a certain level (confirm with trial site).
• You have unexplained high levels of a muscle enzyme called CPK in your blood (confirm with trial site).
• You are unable to have an MRI scan