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

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

Arizona Liver Health - Chandler
Chandler, Arizona 85224

Arizona Liver Health - Peoria
Peoria, Arizona 85381

The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
Tucson, Arizona 85712

Fresno Clinical Research Center
Fresno, California 93720

Gastrointestinal Specialists of Georgia PC
Marietta, California 30060

ClinCloud Research - Maitland
Maitland, Florida 32751

Advanced Clinical Research of Miami
Miami, Florida 33155

Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland 21202

Kansas City Research Institute
Kansas City, Missouri 64131

Coastal Research Institute, LLC
Fayetteville, North Carolina 28304

IMA Clinical Research - Austin, TX
Austin, Texas 78745

American Research Corporation - Austin, TX
Austin, Texas 78757

Pinnacle Clinical Research - Austin, TX
Austin, Texas 78757

Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626

Houston Research Institute - Texas Medical Center
Houston, Texas 77030

Houston Research Institute
Houston, Texas 77079

LinQ Research, LLC
Katy, Texas 77494

Houston Research Institute - Pasadena
Pasadena, Texas 77505

American Research Corporation - San Antonio
San Antonio, Texas 78215

Pinnacle Clinical Research - San Antonio
San Antonio, Texas 78229

Richmond Institute for Veterans Research
Richmond, Virginia 23249

More Details

NCT ID
NCT06920043
Status
Recruiting
Sponsor
Boston Pharmaceuticals

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center