A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Partici… (NCT07704892) | Clinical Trial Compass
RecruitingPhase 3
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
United States380 participantsStarted 2026-07-22
Plain-language summary
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants aged between 18 and 75 years at enrolment.
* Participants with history or presence of at least two components of metabolic syndrome.
* Liver biopsy consistent with cirrhosis (fibrosis stage 4).
Exclusion Criteria:
* Participants with other chronic liver diseases.
* Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
* Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.
* History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.
* A recent history or planned surgical procedures or medications intended to produce significant weight loss.
* Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) \>= 5 times upper limit normal (ULN).
* Current or history of excessive alcohol intake
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH