LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

This study is looking for adult volunteers, aged 18 or older, who have a confirmed diagnosis of MASH (some doctors still call it NASH) and obesity. Importantly, your liver must also show signs of at least moderate or advanced damage, known as fibrosis.

However, you cannot join the study if you have certain other liver conditions, or if your liver is already severely damaged (cirrhosis). You also can't take part if you have other serious liver problems or a history of certain liver cancers. Your doctor will carefully check your liver test results to make sure it's safe for you to join.

If you join the study, you'll be involved for up to seven years. You'll receive weekly injections of either survodutide or the placebo under your skin. The dose of the study medicine will be slowly increased over time. You will also get advice on diet and exercise throughout the study.

For roughly the first year, you'll have visits to the study site or video calls every two weeks, then every four weeks, and then every six weeks. After about a year, these visits will become quarterly (every three months), alternating between in-person appointments and remote video calls until the end of the study. During these visits, doctors will check your general health, measure your body weight, and ask about any side effects. They'll also perform special scans to look at your liver and, at 2 or 3 visits, take a small liver tissue sample (biopsy). You'll also complete questionnaires about your symptoms and how you are feeling.