Cirrhosis and Liver Disease
We're looking for adults aged 18 and older who have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH) * A body mass index (BMI) of 27 or more, or 25 or more if you're Asian. Unfortunately, if you have a history of other chronic liver diseases or high alcohol intake, you won't be able to participate.
Study site: NeoClinical Research
- Metabolic Dysfunction Associated Steatohepatitis
- About the Study
- This study is for adults aged 18 and older who have: * A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH) * A BMI of 27 or more, or 25 or more if you're Asian. If you have other chronic liver diseases or high alcohol intake, you won't be able to participate. We're exploring whether a medicine can help improve liver function for those with NASH or MASH. Participants will be randomly assigned to one of two groups: one will receive the medicine and the other a placebo. You have a better chance of receiving the actual medicine! You'll take an injection once a week and receive guidance on diet and exercise. The study lasts up to 4 and a half years, with visits every 2, 4, or 6 weeks for the first 1 year and 5 months, then every 3 months after that. Doctors will monitor your health, check for any side effects, and measure your weight and liver health. You'll also complete questionnaires about your symptoms. We'll compare the results to see how effective the treatment is.
- What does the study involve?
- You'll receive a weekly injection using a pre-filled 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 with: * A BMI of 27 or more (or 25 or more if you're Asian) * A confirmed diagnosis of NASH or MASH cirrhosis. Unfortunately, if you have a history of significant alcohol consumption, other chronic liver diseases, or certain health conditions, you won't be able to participate. 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
- November 2024 to June 2029 (expected)
- Size
- 1590 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.