Liver Health and NASH
Join our study if you're an adult aged 18 or older living with obesity and have: * a confirmed liver disease called NASH (non-alcoholic steatohepatitis) or MASH (metabolic associated steatohepatitis) and * moderate or advanced liver fibrosis. Unfortunately, if you have a history of other liver diseases or chronic alcohol use, you won't be able to participate. This study aims to see if a new medicine can help improve liver function for those with NASH/MASH and liver fibrosis.
Study site: NeoClinical Research
- Fatty liver disease (MASH/NASH)
- About the Study
- This study is open to adults aged 18 and older who are living with obesity and have: * a confirmed liver disease called NASH (non-alcoholic steatohepatitis) or MASH (metabolic associated steatohepatitis) and * moderate or advanced liver fibrosis. If you have a history of other liver diseases or chronic alcohol use, you won't be able to participate. The study aims to find out if a new medicine can help improve liver function for those with NASH/MASH and liver fibrosis. The study has two parts. The first part looks at how the medicine affects NASH/MASH and liver fibrosis. The second part checks how safe and effective the medicine is for improving liver function. Participants will be randomly placed into two groups: one group will receive the medicine, and the other will receive a placebo. You have a better chance of getting the actual medicine! Neither participants nor doctors will know who is in which group. Participants will inject the medicine or placebo under the skin once a week, with doses gradually increasing until the target dose is reached. Everyone will also receive support to help with diet and exercise. Participants will be in the study for up to 7 years, with regular visits to the study site or remote check-ins via video call. In the first year, visits will be every 2 weeks, then every 4 weeks, and later every 6 weeks. After a little over a year, visits will alternate between in-person and remote every 3 months until the study ends. Doctors will monitor your health and any side effects, check your weight, and assess your stomach and intestines regularly. Some visits will include imaging tests to check your liver, and a few will involve taking a small sample of liver tissue (biopsy). You'll also fill out questionnaires about your symptoms and quality of life. The results will help us see if the treatment works.
- What does the study involve?
- You'll receive a weekly injection under the skin using a prefilled syringe.
What to expect
- Placebo
- You may receive a placebo (a look-alike with no active medicine).
- Which treatment you get
- Chosen at random. Neither you nor the study team will know which treatment you get.
- Who can participate?
- We're looking for adults aged 18 and older who have: * a diagnosis of NASH or MASH with a specific activity score, * stable body weight for 3 months before the study, and * a willingness to maintain a healthy diet and exercise during the study. If you have certain liver test abnormalities or other liver diseases, you may not qualify. Think you might qualify? Apply to find out!
Where is the study taking place?
Palmetto Medical Plaza
Study details
- Sponsor
- Boehringer Ingelheim
- Phase
- Phase 3: confirming it works in a large group, often against current treatment
- Dates
- October 2024 to December 2031 (expected)
- Size
- 1800 participants across all sites
- Healthy volunteers
- Only people with the condition
Study details are from ClinicalTrials.gov. The rest of this page is written by the study site for patients and may summarize or reword the registry record, which is the official text. A study listed on ClinicalTrials.gov has not necessarily been reviewed or approved by the U.S. government.
About NeoClinical Research
NeoClinical Research is a leading, multi-therapeutic clinical research center based in South Florida that bridges the gap between leading pharmaceutical companies and diverse patient populations.