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Researchers are evaluating whether two drugs, retatrutide and tirzepatide, can prevent serious liver problems in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk based on non-invasive tests. This Phase 3 randomized clinical trial plans to enroll about 4,500 adults and will last approximately 224 weeks, including up to 25 to 30 clinic visits to monitor health and liver disease progression. The study is sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. After completing the main study, eligible participants may join a 2-year extension where everyone receives either retatrutide or tirzepatide, regardless of their original group. This Master Protocol evaluates multiple pharmacologic agents under controlled conditions. Throughout the study, participants will undergo various assessments including liver function tests, imaging to measure liver stiffness and fat content, and body weight measurements. Researchers will track the time to major adverse liver outcomes and cardiovascular events. Safety and disease progression will be closely monitored, and the study includes evaluations at baseline, week 104, and up to study completion.

Researchers are investigating whether survodutide can improve liver function in adults diagnosed with non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH) who also have cirrhosis and a body mass index (BMI) of 27 or higher, or 25 or higher for Asian participants. This phase III trial randomly assigns participants to receive either the medication survodutide or a placebo, with twice the chance of receiving survodutide. The study is double-blinded, meaning neither participants nor doctors know which treatment is given, to fairly evaluate the effects of the medication compared to placebo. Participants inject survodutide or placebo under the skin once a week and receive regular counseling to support diet and exercise changes. The study lasts up to 4.5 years, with frequent visits either in person or via video calls every 2, 4, or 6 weeks for about 17 months. After this period, visits occur every 3 months until the study concludes. This approach allows close monitoring of treatment effects and adherence. Throughout the study, doctors assess participants' health, monitor for side effects, and regularly measure body weight. Liver health is evaluated using imaging techniques and blood tests at specific visits. Participants also complete symptom questionnaires. The main goal is to measure the time until certain serious liver-related events occur, while secondary goals include changes in liver fibrosis, liver stiffness, blood sugar levels, and body weight. This comprehensive evaluation helps determine the medication's impact over the long term.

Researchers are evaluating whether a medicine called survodutide can help adults living with obesity who have a liver disease known as non-alcoholic steatohepatitis (NASH) or metabolic associated steatohepatitis (MASH) combined with moderate or advanced liver fibrosis. This phase III trial aims to find out if survodutide improves liver function and safety over a long period. Participants with other liver diseases or chronic alcohol intake are not eligible. The study has two parts. In the first part, participants are randomly assigned to receive either survodutide or a placebo, with twice the chance of getting survodutide. Both groups inject their assigned treatment under the skin once a week, with doses gradually increasing to a target level. All participants also receive counselling on diet and exercise. The second part focuses on how safe and effective survodutide is over time. Participants stay in the study for up to seven years, with regular visits either in person or through video calls. For about the first year, visits occur every two weeks, then every four weeks, then every six weeks. After the first year, visits alternate between in person and remote every three months. Doctors monitor participants’ health, body weight, and gastrointestinal effects. Liver health is checked using imaging methods and sometimes liver biopsies. Participants also complete questionnaires about symptoms and quality of life. The study measures whether survodutide helps improve liver disease compared to placebo.