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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

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

OM Research LLC
Lancaster, California 93534

Knowledge Research Center
Orange, California 92868

California Liver Research Institute
Pasadena, California 91105

Inland Empire Liver Foundation
Rialto, California 92377

Santa Maria Gastroenterology Center
Santa Maria, California 93458

ClinCloud Research - Viera
Melbourne, Florida 32940

Advanced Clinical Research of Miami
Miami, Florida 33155

Centricity Research - Columbus
Columbus, Georgia 31904

Gastrointestinal Specialists of Georgia PC
Marietta, Georgia 30060

Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland 21202

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

Kansas City Research Institute
Kansas City, Missouri 64131

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

Coastal Research Institute, LLC
Fayetteville, North Carolina 28304

M3 Wake Research, Inc
Raleigh, North Carolina 27612

IMA Clinical Research - Austin, TX
Austin, Texas 78745

American Research Corporation - Austin, TX
Austin, Texas 78757

Pinnacle Clinical Research - Austin, TX
Austin, Texas 78757

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

Pinnacle Clinical Research - Georgetown
Georgetown, Texas 78626

Baylor College of Medicine
Houston, Texas 77030

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

Velocity Clinical Research - Waco
Waco, Texas 76710

Richmond Institute for Veterans Research
Richmond, Virginia 23249

GI Alliance - Washington Gastroenterology
Tacoma, Washington 98405

More Details

NCT ID
NCT06920043
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.

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