A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) MASH

Last updated: May 19, 2025
Sponsor: Boston Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Treatment

Efimosfermin

Placebo

Clinical Study ID

NCT06920043
BOS-580-202
  • Ages 18-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Individuals with chronic liver disease from other causes, or any history or evidenceof decompensated liver disease

  • History of type 1 diabetes

  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upperlimit of normal (ULN)

  • Other exclusion criteria may apply.

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Efimosfermin
Phase: 2
Study Start date:
April 09, 2025
Estimated Completion Date:
November 30, 2027

Connect with a study center

  • Arizona Liver Health - Chandler

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Arizona Liver Health - Peoria

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • Fresno Clinical Research Center

    Fresno, California 93720
    United States

    Active - Recruiting

  • OM Research LLC

    Lancaster, California 93534
    United States

    Site Not Available

  • Gastrointestinal Specialists of Georgia PC

    Marietta, California 30060
    United States

    Active - Recruiting

  • Knowledge Research Center

    Orange, California 92868
    United States

    Site Not Available

  • California Liver Research Institute

    Pasadena, California 91105
    United States

    Site Not Available

  • Inland Empire Liver Foundation

    Rialto, California 92377
    United States

    Site Not Available

  • Santa Maria Gastroenterology Center

    Santa Maria, California 93458
    United States

    Site Not Available

  • ClinCloud Research - Maitland

    Maitland, Florida 32751
    United States

    Site Not Available

  • Advanced Clinical Research of Miami

    Miami, Florida 33155
    United States

    Active - Recruiting

  • Centricity Research - Columbus

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Mercy Medical Center - Baltimore, Maryland

    Baltimore, Maryland 21202
    United States

    Active - Recruiting

  • Gastrointestinal Associates and Endoscopy Center, PA - Flowood

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Kansas City Research Institute

    Kansas City, Missouri 64131
    United States

    Active - Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Site Not Available

  • Tandem Intermediate, LLC - New York

    New York, New York 10033
    United States

    Site Not Available

  • Coastal Research Institute, LLC

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • M3 Wake Research, Inc

    Raleigh, North Carolina 27612
    United States

    Site Not Available

  • American Research Corporation - Austin, TX

    Austin, Texas 78757
    United States

    Active - Recruiting

  • IMA Clinical Research - Austin, TX

    Austin, Texas 78745
    United States

    Active - Recruiting

  • Pinnacle Clinical Research - Austin, TX

    Austin, Texas 78757
    United States

    Active - Recruiting

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas 75203
    United States

    Site Not Available

  • Zenos Clinical Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Pinnacle Clinical Research - Georgetown

    Georgetown, Texas 78626
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Research Institute

    Houston, Texas 77079
    United States

    Site Not Available

  • LinQ Research, LLC

    Katy, Texas 77494
    United States

    Site Not Available

  • American Research Corporation - San Antonio

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Velocity Clinical Research - Waco

    Waco, Texas 76710
    United States

    Site Not Available

  • Richmond Institute for Veterans Research

    Richmond, Virginia 23249
    United States

    Site Not Available

  • GI Alliance - Washington Gastroenterology

    Tacoma, Washington 98405
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.