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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

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

ArmDescriptionAssigned Intervention
Experimental
Efimosfermin (Dose 1) 		Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).
  • Drug: Efimosfermin
    Efimosfermin will be administered as a subcutaneous injection.
    Other names:
    • BOS-580
Experimental
Efimosfermin (Dose 2) 		Participants will receive efimosfermin (Dose 2) Q4W.
  • Drug: Efimosfermin
    Efimosfermin will be administered as a subcutaneous injection.
    Other names:
    • BOS-580
Placebo Comparator
Placebo 		Participants will receive placebo Q4W.
  • Drug: Placebo
    Placebo will be administered as a subcutaneous injection.

Recruiting Locations

Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626

More Details

Status
Recruiting
Sponsor
Boston Pharmaceuticals

Study Contact

Patricia Mendez, MD
617-826-0300
patricia.mendez@bostonpharmaceuticals.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.