A Study of Efruxifermin for Cirrhosis Due to NASH/MASH
This study is evaluating efruxifermin in people with compensated cirrhosis (advanced scarring of the liver) caused by NASH (Nonalcoholic Steatohepatitis) or MASH (Metabolic Dysfunction-Associated Steatohepatitis). You may be able to join if you are between 18 and 80 years old and have biopsy-proven or non-invasively diagnosed compensated cirrhosis due to NASH/MASH. The study will compare efruxifermin to a placebo (an inactive substance) given by injection under the skin. Researchers want to see if efruxifermin can delay serious liver-related events over 5 years. For some participants, they will also look for improvement in liver scarring without worsening of steatohepatitis (liver inflammation and fat) after 96 weeks. The current recruitment status is unclear, but the study plans to enroll 2150 participants.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either efruxifermin or a placebo, and neither you nor your doctor will know which you are receiving. The study aims to enroll 2150 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 5 years to track significant clinical events. For some participants, liver changes will be assessed at 96 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
At a glance
Conditions
NCT06528314
Where you'd take part
This study runs at 331 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Akero Clinical Study Site
Birmingham, Alabamano site contact published
Recruiting
Akero Clinical Study Site
Dothan, Alabamano site contact published
Recruiting
Akero Clinical Study Site
Chandler, Arizonano site contact published
Recruiting
Akero Clinical Study Site
Peoria, Arizonano site contact published
Recruiting
Akero Clinical Study Site
Scottsdale, Arizonano site contact published
Recruiting
Akero Clinical Study Site
Tucson, Arizonano site contact published
Recruiting
Akero Clinical Study Site
Tucson, Arizonano site contact published
Recruiting
Akero Clinical Study Site
Tucson, Arizonano site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Time from randomization to the first significant clinical event including disease progression, liver decompensation events, etc.5 years
Measured by composite of protocol-specified clinical events
- Cohort 1 only: Proportion of subjects with ≥ 1 stage improvement in fibrosis and no worsening of steatohepatitis96 Weeks
Based on NASH CRN fibrosis score (scored by a fibrosis score of 0-4, where 0 = no fibrosis, 1 = centrilobular pericellular fibrosis, 2 = centrilobular and periportal fibrosis, 3 = bridging fibrosis, 4 = cirrhosis)