Purpose of this Study
This study has two parts. In the first part, people will be placed into one of two groups by chance. One group will receive a medicine called efimosfermin, and the other group will receive a placebo, which has no active medicine. The medicine is given as a shot every four weeks for about 92 weeks.
People who finish the first part may be able to join the second part of the study. In this part, everyone receives efimosfermin every four weeks for about 152 weeks.
The study lasts a little over five years. During this time, participants will have many clinic visits and phone contacts. They will have blood tests, liver scans, ultrasound exams, liver biopsies, and questionnaires about their health. Participants will also visit the study center every month to receive the study medicine.
Who Can Participate?
Eligibility
People may be able to join this study if they are between 18 and 75 years old and have a liver disease called MASH, which happens when fat builds up in the liver and causes damage. They must have severe liver scarring, called stage 4 fibrosis or cirrhosis, confirmed by a liver biopsy. Researchers are studying new treatments to see if they can improve liver health and help prevent problems caused by advanced liver disease.
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 testing a medicine called efimosfermin in people who have severe liver disease caused by MASH. MASH is a condition where fat builds up in the liver and causes damage over time. Researchers want to learn if efimosfermin can improve liver health and lower the chance of serious problems caused by liver cirrhosis. The goal is to find out if this medicine can help people with this liver disease stay healthier and avoid complications in the future.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, two-part, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis (stage F4 fibrosis) due to metabolic dysfunction-associated steatohepatitis (NEBULA-2)
Principal Investigator
Amreen
Dinani
Protocol Number
PRO00120975
NCT ID
NCT07704892
Phase
III
Enrollment Status
Pending Open to Enrollment