Phase 2 Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from 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 with a body mass index (BMI) of 28 or higher at the screening visit
• People with high fasting triglyceride levels (a type of fat in the blood) of 350 mg/dL or above
• People without diabetes, or people with diabetes whose blood sugar control (HbA1c) is below 9.5%
• People whose blood test results for kidney function, liver enzymes, clotting, and platelet levels fall within the ranges set by the trial protocol
• People who have been diagnosed with a liver condition called NAFLD or NASH within the past 5 years, confirmed by liver imaging or a liver biopsy, and who have not lost more than 5% of their body weight since that diagnosis
• People with normal blood pressure, or whose blood pressure is not above 155/90 mmHg at screening
• People whose heart tracing (ECG) at screening is normal or shows only minor changes considered not significant by the trial doctor
• Women who could become pregnant must have a negative pregnancy test at screening and before the first dose of the study drug
• People who are sexually active with a partner of the opposite sex and could potentially conceive must agree to use contraception methods specified by the trial protocol

Who may not be able to join:

• People with an HbA1c (blood sugar control measure) of 9.5% or higher at screening
• People who have lost more than 5% of their body weight in the 90 days before screening
• People who are pregnant or breastfeeding
• People whose current alcohol use is judged by the trial doctor to potentially affect their safety or ability to follow the trial requirements
• People whose current use of other substances is judged by the trial doctor to potentially affect their safety or ability to follow the trial requirements
• People who test positive for HIV, hepatitis B, or hepatitis C
• People with a history of liver disease other than NAFLD/NASH, such as alcoholic liver disease, autoimmune liver conditions, drug-related liver damage, or certain inherited liver conditions
• People with any history of advanced scarring of the liver (cirrhosis) or serious liver complications such as fluid build-up in the abdomen, confusion caused by liver disease, or bleeding from swollen veins in the digestive tract
• People with unstable heart or cardiovascular disease
• People who have had part of their intestine removed or have a condition that affects the absorption of food and medication (note: removal of the appendix or gallbladder is not a reason for exclusion)
• People with severe stomach ulcers, significant acid reflux, or other conditions involving excess stomach acid, in the opinion of the trial doctor
• People who have planned surgery during the trial period, except for minor procedures done under local anaesthetic, in the opinion of the trial doctor
• People with a history of cancer in the past 5 years, with some exceptions for certain treated skin cancers or cervical changes (confirm with trial site)
• People with a history of serious allergic reactions to medications, in the opinion of the trial doctor
• People with a known allergy or sensitivity to the study drug or its ingredients
• People with any medical or psychiatric condition that the trial doctor believes could affect their ability to safely participate, including a psychiatric hospital admission or emergency room visit for mental health reasons within the past 2 years
• People with abnormal blood test results that the trial doctor believes could affect safety or the reliability of the trial results
• People who have used any prescription or over-the-counter weight loss medication or treatment in the 90 days before screening
• People who have received a COVID-19 vaccine or any other live vaccine within 14 days before the planned first dose of the study drug

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