Purpose of this Study
If you are able to join this study, you will be placed by chance into one of three groups. One group will get 225 milligrams of the study drug GSK6519754, another will get 300 milligrams, and the third group will get a placebo, which has no medicine. You will get your assigned injection once every four weeks for four years. During the study, which lasts a little over four years, you will have at least fifty four visits. At these visits, you will have blood tests, body and liver scans, ultrasounds, a liver biopsy, and questionnaires to check your health and how the treatment is working.
Who Can Participate?
Eligibility
People can join this study if they are between 18 and 75 years old and have metabolic syndrome now or had it in the past. They must also have MASH confirmed by a liver biopsy and must have kept a steady body weight for the last six months. People cannot join if they cannot safely have a liver biopsy, have another kind of long term liver disease, have had pancreas problems, have type 1 diabetes or serious problems from type 2 diabetes, or have major bone diseases like osteoporosis.
Age Range
18-75
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 being done to find out if a new medicine called GSK6519754 can help people who have MASH, a liver disease caused by too much fat and inflammation in the liver. Researchers want to see if this medicine can lower liver fat, reduce swelling in the liver, and improve overall liver health.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-1)
Principal Investigator
Amreen
Dinani
Protocol Number
PRO00119961
NCT ID
NCT07221227
Phase
III
Enrollment Status
Pending Open to Enrollment