Purpose of this Study
Participants will be randomly assigned to receive either the study drug or a placebo by injection every 4 weeks. Participation may last 5 to 7 years and includes monthly visits, phone visits, blood tests, body scans, ultrasounds, questionnaires, and regular study drug injections.
Who Can Participate?
Eligibility
Participants may be able to join if they are adults with liver cirrhosis caused by MASH and are overweight or obese with high triglyceride levels. They cannot have HIV, chronic hepatitis B or C, or type 1 diabetes.
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 whether a study drug can improve liver health and lower the risk of liver problems in people with liver cirrhosis caused by MASH, a type of fatty liver disease.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Phase 3, double-blind, randomized, placebo controlled, 2-arm study to investigate the safety and efficacy of efimosfermin alfa injection in adult participants with compensated cirrhosis due to metabolic dysfunction-associated steatohepatitis (NEBULA-1)
Principal Investigator
Amreen
Dinani
Protocol Number
PRO00121121
NCT ID
NCT07701993
Phase
III
Enrollment Status
Pending Open to Enrollment