Overview
Liver Scarring Research Study: Clinical Trial for NASH/MASH Liver Scarring
The study is a clinical trial for adults with non-cirrhotic nonalcoholic steatohepatitis (NASH) or metabolic dysfunction-associated steatohepatitis (MASH). NASH/MASH starts with a build-up of fat in the liver, damage to liver cells, and soreness, which eventually leads to scarring or cirrhosis.
The study will test an investigational drug to see whether it helps slow or possibly reverse fibrosis (scarring of the liver) and to learn about any side effects.
About the Study
Find out more about a clinical trial of an investigational drug for nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH).
Participants will be randomly assigned (as if choosing names out of a hat) to take either a 28 mg /50 mg of the study medication or a placebo, which looks like the medicine but has no active ingredients. There is a 2 in 3 (66%) chance of getting the study drug, but you will not be able to choose. Whichever group you are in, you will give yourself an injection once a week, along with taking your usual medications. Your study doctor will teach you how to give yourself the injection.
Data protection of all participants is very important to us. We will take all precautions to keep participant identity and personal information safe.
Who Can Join
You may be able to join the study if you:
- Are from 18 to 80 years old
- Have had a liver biopsy that showed NASH/MASH or are willing to undergo a biopsy
- Have a BMI greater than 25
- Have or ever had type 2 diabetes or 2 out of 4 signs of metabolic syndrome
- overweight
- have high cholesterol
- elevated blood pressure
- elevated fasting blood glucose
Not sure if you qualify?
A member of our study team will review your medical history and medications with you to determine if this study may be a good fit.
What to Expect
Study Duration
The study lasts about 256 weeks
- Study Phases:
- 12-week screening period
- followed by a treatment period of up to 240 weeks
- followed by a follow-up visit 30 days after the last study dose
Study Visits
Approximately 36 study visits
Compensation
Compensation up to $1470 may be available for time and travel.
Procedures During the Study
Everyone in the study will need to have a liver tissue sample that shows they have NASH/MASH. A needle-core liver biopsy will be done at Week 52 (Cohort 1 only), Week 96 (Cohort 2 only) and compared against the screening biopsy. All subjects will undergo another liver biopsy at Week 240.