Purpose of this Study
If people join this study, they will be placed into one of two groups by chance. One group will receive a medicine called survodutide, and the other group will receive a placebo, which has no active medicine. Participants will have about 20 study visits, including visits at the clinic and video calls from home.
During the study, participants will complete different health tests and activities. These may include blood tests, procedures to look inside the digestive system, liver biopsies, ultrasound scans, questionnaires, and electronic diaries. Researchers will use this information to learn how safe and effective the treatment is for people with liver disease.
Who Can Participate?
Eligibility
People can join this study if they are adults and have a liver disease called MASH, which happens when fat builds up in the liver and causes inflammation and damage. They must have moderate liver scarring, called Stage F2 or F3 fibrosis, confirmed by a recent liver biopsy.
Participants should have had a stable body weight for the past few months without major weight changes. They must also have test results showing signs of liver disease, such as increased liver stiffness and extra fat in the liver. These tests help doctors make sure the study is right for them before they join.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing a new medicine called survodutide in people who have a liver disease called NASH or MASH. This disease happens when fat builds up in the liver and causes damage and scarring. The study includes people who have moderate liver scarring but do not have severe liver disease called cirrhosis.
Researchers want to find out if survodutide can help improve liver health and reduce liver damage. The goal is to learn if this medicine is a safe and effective treatment for people with NASH or MASH and liver fibrosis.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A randomised, double-blind, placebo-controlled, multicentre,
Phase III trial evaluating long-term efficacy and safety of
survodutide weekly injections in adult participants with noncirrhotic
non-alcoholic steatohepatitis/metabolic dysfunctionassociated
steatohepatitis (NASH/MASH) and (F2) - (F3) stage
of liver fibrosis
Phase III trial evaluating long-term efficacy and safety of
survodutide weekly injections in adult participants with noncirrhotic
non-alcoholic steatohepatitis/metabolic dysfunctionassociated
steatohepatitis (NASH/MASH) and (F2) - (F3) stage
of liver fibrosis
Principal Investigator
Amreen
Dinani
Protocol Number
PRO00120826
NCT ID
NCT06632444
Phase
III
Enrollment Status
Pending Open to Enrollment