A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) MASH
Purpose
The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.
Condition
- Metabolic Dysfunction-Associated Steatohepatitis
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Ability to understand and sign a written informed consent form (ICF) - Age 18 through 75 years at enrollment - History or presence of 2 or more of the 5 components of metabolic syndrome - Liver biopsy confirmation of MASH consistent with stage F4 fibrosis - Other inclusion criteria may apply.
Exclusion Criteria
- Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease - History of type 1 diabetes - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN) - Other exclusion criteria may apply.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Efimosfermin (Dose 1) |
Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W). |
|
|
Experimental Efimosfermin (Dose 2) |
Participants will receive efimosfermin (Dose 2) Q4W. |
|
|
Placebo Comparator Placebo |
Participants will receive placebo Q4W. |
|
Recruiting Locations
Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626
Georgetown, Texas 78626
More Details
- Status
- Recruiting
- Sponsor
- Boston Pharmaceuticals