A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed Fā¦ (NCT07221227) | Clinical Trial Compass
RecruitingPhase 3
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
United States1,200 participantsStarted 2025-10-24
Plain-language summary
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
ā. Age \>=18 and \<=75 years at enrollment
ā. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
ā. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist
Exclusion criteria
ā. Contraindication or ineligibility for percutaneous liver biopsy
ā. ALT or AST \>=5 x upper limit of normal (ULN)
ā. Total bilirubin \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of \>=1.3 mg/dL and direct bilirubin is \<=20% of total bilirubin; otherwise, the individual will be excluded.
ā. Serum albumin \<=3.5 grams per deciliter (g/dL)
ā. International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
ā. Alkaline phosphatase (ALP) \>=2\*ULN
ā. Platelet (PLT) count \<140,000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor.
What they're measuring
1
Proportion of participants experiencing improvement in fibrosis by >=1 stage and no worsening of steatohepatitis at Week 52
Timeframe: At Week 52
2
Proportion of participants experiencing resolution of steatohepatitis reading and no worsening of MASH CRN fibrosis score at Week 52
Timeframe: At Week 52
3
Time from randomization to an adjudicated composite liver-related clinical outcome
Timeframe: From Randomization (Day 1) to 48 months