A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to 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 5289282, Arizona 5551752 85224

Arizona Liver Health - Peoria
Peoria 5308480, Arizona 5551752 85381

The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
Tucson 5318313, Arizona 5551752 85712

Fresno Clinical Research Center
Fresno 5350937, California 5332921 93720

OM Research LLC
Lancaster 5364940, California 5332921 93534

Knowledge Research Center
Orange 5379513, California 5332921 92868

California Liver Research Institute
Pasadena 5381396, California 5332921 91105

Inland Empire Liver Foundation
Rialto 5387288, California 5332921 92377

Santa Maria Gastroenterology Center
Santa Maria 5393180, California 5332921 93458

ClinCloud Research - Viera
Melbourne 4163971, Florida 4155751 32940

Advanced Clinical Research of Miami
Miami 4164138, Florida 4155751 33155

Centricity Research - Columbus
Columbus 4188985, Georgia 4197000 31904

Gastrointestinal Specialists of Georgia PC
Marietta 4207783, Georgia 4197000 30060

Mercy Medical Center - Baltimore, Maryland
Baltimore 4347778, Maryland 4361885 21202

Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood 4426822, Mississippi 4436296 39232

Kansas City Research Institute
Kansas City 4393217, Missouri 4398678 64131

Icahn School of Medicine at Mount Sinai
New York 5128581, New York 5128638 10029

Coastal Research Institute, LLC
Fayetteville 4466033, North Carolina 4482348 28304

M3 Wake Research, Inc
Raleigh 4487042, North Carolina 4482348 27612

IMA Clinical Research - Austin, TX
Austin 4671654, Texas 4736286 78745

American Research Corporation - Austin, TX
Austin 4671654, Texas 4736286 78757

Pinnacle Clinical Research - Austin, TX
Austin 4671654, Texas 4736286 78757

The Liver Institute at Methodist Dallas Medical Center
Dallas 4684888, Texas 4736286 75203

Pinnacle Clinical Research - Georgetown
Georgetown 4693342, Texas 4736286 78626

Baylor College of Medicine
Houston 4699066, Texas 4736286 77030

Houston Research Institute - Texas Medical Center
Houston 4699066, Texas 4736286 77030

Houston Research Institute
Houston 4699066, Texas 4736286 77079

LinQ Research, LLC
Katy 4702732, Texas 4736286 77494

Houston Research Institute - Pasadena
Pasadena 4717782, Texas 4736286 77505

American Research Corporation - San Antonio
San Antonio 4726206, Texas 4736286 78215

Pinnacle Clinical Research - San Antonio
San Antonio 4726206, Texas 4736286 78229

Velocity Clinical Research - Waco
Waco 4739526, Texas 4736286 76710

Richmond Institute for Veterans Research
Richmond 4781708, Virginia 6254928 23249

GI Alliance - Washington Gastroenterology
Tacoma 5812944, Washington 5815135 98405

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