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Metabolic dysfunction associated steatotic liver disease, or MASLD, is a liver disease caused by too much fat building up in your liver. Over time, this can lead to liver inflammation and other liver problems. This study wants to find out whether tirzepatide or retatrutide can help improve liver health and slow the disease down. Before joining the study, you will have a visit to see if you can join the study. This visit may include a physical exam, a liver scan, an MRI scan, and an electrocardiogram (EKG). You will also give small amounts of blood for tests and answer questions about your health history. If you qualify, you will be randomly assigned to one of two study groups, like flipping a coin. You cannot choose your group. If you are assigned to group 1, you may get the study drug tirzepatide or a placebo. A placebo looks like the study drug but has no active medicine. Neither you nor the study team will know which study drug you will be taking. If you are assigned to group 2, you may get the study drug retatrutide or a placebo. Both groups will take the study drug through a weekly injection. You will take the injection regularly throughout the 5 years you will be in the study. You will have about 25 to 30 in person visits while you participate in the study. All study visits will require you to not eat or drink anything before you come to the clinic. At some visits, we may also do an endoscopy by inserting a thin, flexible tube with a camera through your mouth into your stomach. This allows the study doctor to look at your upper digestive system. Similarly, you may have a liver biopsy at some visits. This is where a small piece of your liver is removed to see if your liver condition is getting worse. You and your insurance will need to pay for your routine care. You may earn up to $9,300 for completing all study visits. A caregiver, such as a family member or friend who helps bring you to certain visits, may receive up to $341 for needing to take you to certain visits.

Who can Participate

You may be able to join the study if you are at least 18 years old and have high risk metabolic dysfunction associated steatotic liver disease. You cannot join the study if you have any other form of liver disease that is not metabolic dysfunction associated steatotic liver disease, or have a BMI below 25, or have lost more than 11 pounds within 3 months before joining the study, or have type 1 diabetes. You also cannot join this study if you are pregnant, planning to be pregnant, breastfeeding, or planning to breastfeed.

Study ID

More information available at ClinicalTrials.gov: NCT07165028