Purpose of this Study
If you can join this study, you will be placed by chance into one of three groups. One group will get 225 milligrams of the study medicine called GSK6519754, another group will get 300 milligrams, and the third group will get a placebo, which has no medicine. Most people will receive the study medicine. You will get the injection once every four weeks for several years. During the study, you will come to the clinic many times. At these visits, doctors will do blood tests, body and liver scans, ultrasounds, and ask you to fill out questionnaires to check your health and how the treatment is working.
Who Can Participate?
Eligibility
People may be able to join this study if they are between 18 and 75 years old. They must have, or may have, a liver disease called MASH. They also need to have at least two health conditions linked to metabolic syndrome, such as problems with blood sugar, cholesterol, blood pressure, or body weight.
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 learn if a new medicine called GSK6519754 can help people who have a liver disease called MASH. MASH happens when too much fat builds up in the liver and causes swelling and damage. Researchers want to see if this medicine can lower fat in the liver, reduce inflammation, and help the liver stay healthier.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
Principal Investigator
Amreen
Dinani
Protocol Number
PRO00120207
NCT ID
NCT07221188
Phase
III
Enrollment Status
Pending Open to Enrollment