Overview
Liver Disease Research Study: Clinical Trial for Compensated Cirrhosis due to NASH/MASH
Nonalcoholic steatohepatitis (NASH), now called metabolic dysfunction-associated steatohepatitis (MASH) is a type of nonalcoholic liver disease that starts with a buildup of fat in the liver. The fat causes inflammation and damage to liver cells, which eventually leads to scarring of the liver.
This study is evaluating an investigational medicine to see whether it will help in the treatment of compensated cirrhosis due to NASH/MASH.
About the Study
The study is a clinical trial to see what effect an investigational medicine has on scarring of the liver in compensated cirrhosis due to NASH/MASH.
The study has 2 parts; Part 1 requires a liver biopsy at two points during the study (at Screening and Week 96).
Who Can Join
You may be able to join if you:
- Are 18 to 80 years old
- Have compensated cirrhosis due to NASH/MASH (this means there is significant scar formation in the liver)
- Have a BMI greater than 25
- Have or ever had type 2 diabetes or have 2 out of 4 signs of metabolic syndrome:
- obesity
- high cholesterol/triglyceride levels
- high blood pressure
- and/or high 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 may last up to 5 years and 4 months.
- Screening period: 3 months
- Treatment period: 5 years.
- Follow-up: 30 days after your last injection.
After the initial screening and baseline phases, visits generally occur every 12 to 48 weeks during the long-term treatment period.
Study Visits
Up to 39 visits to the Study Doctor
Compensation
Travel reimbursement and travel support for participants may be offered throughout the study. Compensation up to $1440 may be available for time and travel.
Procedures During the Study
The study medicine is an injection you give to yourself once a week.