A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Par… (NCT07221188) | Clinical Trial Compass
RecruitingPhase 3
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
United States1,250 participantsStarted 2025-12-12
Plain-language summary
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
* Age \>=18 through \<=75 years at enrolment
* History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
* History or presence of known or suspected MASH with evidence of fibrosis
Exclusion Criteria:
* ALT or AST \>=5 × upper limit of normal (ULN)
* Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded.
* Serum albumin \<=3.5 grams per deciliter (g/dL)
* 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.
* Alkaline phosphatase (ALP) \>=2 × ULN
* 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
* Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation.
* Alpha-fetoprotein \>=20 nanogram…
What they're measuring
1
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Timeframe: At Week 52
2
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Timeframe: At Week 52
3
Number of participants with Grade 3 and Grade 4 laboratory abnormalities