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

Last updated: December 23, 2025
Sponsor: Boston Pharmaceuticals
Overall Status: Active - Recruiting

Phase

2

Condition

Scar Tissue

Treatment

Efimosfermin

Placebo

Clinical Study ID

NCT06920043
306301 (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:
December 31, 2027

Connect with a study center

  • Arizona Liver Health - Chandler

    Chandler, Arizona 85224
    United States

    Site Not Available

  • Arizona Liver Health - Peoria

    Peoria, Arizona 85381
    United States

    Site Not Available

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

    Tucson, Arizona 85712
    United States

    Site Not Available

  • Arizona Liver Health - Chandler

    Chandler 5289282, Arizona 5551752 85224
    United States

    Active - Recruiting

  • Arizona Liver Health - Peoria

    Peoria 5308480, Arizona 5551752 85381
    United States

    Active - Recruiting

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

    Tucson 5318313, Arizona 5551752 85712
    United States

    Active - Recruiting

  • Fresno Clinical Research Center

    Fresno, California 93720
    United States

    Site Not Available

  • OM Research LLC

    Lancaster, California 93534
    United States

    Site Not Available

  • Gastrointestinal Specialists of Georgia PC

    Marietta, California 30060
    United States

    Site Not Available

  • Gastrointestinal Specialists of Georgia PC

    Murrieta, California 30060
    United States

    Site Not Available

  • Knowledge Research Center

    Orange, California 92868
    United States

    Site Not Available

  • California Liver Research Institute

    Pasadena, California 91105
    United States

    Active - Recruiting

  • 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

  • Gastrointestinal Specialists of Georgia PC

    Forest 5349916, California 5332921 30060
    United States

    Site Not Available

  • Fresno Clinical Research Center

    Fresno 5350937, California 5332921 93720
    United States

    Active - Recruiting

  • OM Research LLC

    Lancaster 5364940, California 5332921 93534
    United States

    Active - Recruiting

  • Knowledge Research Center

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • California Liver Research Institute

    Pasadena 5381396, California 5332921 91105
    United States

    Active - Recruiting

  • Inland Empire Liver Foundation

    Rialto 5387288, California 5332921 92377
    United States

    Active - Recruiting

  • Santa Maria Gastroenterology Center

    Santa Maria 5393180, California 5332921 93458
    United States

    Active - Recruiting

  • ClinCloud Research - Maitland

    Maitland, Florida 32751
    United States

    Site Not Available

  • Advanced Clinical Research of Miami

    Miami, Florida 33155
    United States

    Site Not Available

  • ClinCloud Research - Maitland

    Maitland 4163220, Florida 4155751 32751
    United States

    Site Not Available

  • ClinCloud Research - Viera

    Melbourne 4163971, Florida 4155751 32940
    United States

    Active - Recruiting

  • Advanced Clinical Research of Miami

    Miami 4164138, Florida 4155751 33155
    United States

    Active - Recruiting

  • Centricity Research - Columbus

    Columbus, Georgia 31904
    United States

    Site Not Available

  • Centricity Research - Columbus

    Columbus 4188985, Georgia 4197000 31904
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia PC

    Marietta 4207783, Georgia 4197000 30060
    United States

    Active - Recruiting

  • Mercy Medical Center - Baltimore, Maryland

    Baltimore, Maryland 21202
    United States

    Site Not Available

  • Mercy Medical Center - Baltimore, Maryland

    Baltimore 4347778, Maryland 4361885 21202
    United States

    Active - Recruiting

  • Gastrointestinal Associates and Endoscopy Center, PA - Flowood

    Flowood, Mississippi 39232
    United States

    Site Not Available

  • Gastrointestinal Associates and Endoscopy Center, PA - Flowood

    Flowood 4426822, Mississippi 4436296 39232
    United States

    Active - Recruiting

  • Kansas City Research Institute

    Kansas City, Missouri 64131
    United States

    Site Not Available

  • Kansas City Research Institute

    Kansas City 4393217, Missouri 4398678 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

  • Icahn School of Medicine at Mount Sinai

    New York 5128581, New York 5128638 10029
    United States

    Active - Recruiting

  • Tandem Intermediate, LLC - New York

    New York 5128581, New York 5128638 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

  • Coastal Research Institute, LLC

    Fayetteville 4466033, North Carolina 4482348 28304
    United States

    Active - Recruiting

  • M3 Wake Research, Inc

    Raleigh 4487042, North Carolina 4482348 27612
    United States

    Active - Recruiting

  • American Research Corporation - Austin, TX

    Austin, Texas 78757
    United States

    Active - Recruiting

  • IMA Clinical Research - Austin, TX

    Austin, Texas 78745
    United States

    Site Not Available

  • 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

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Houston Research Institute

    Houston, Texas 77079
    United States

    Active - Recruiting

  • Houston Research Institute - Texas Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • LinQ Research, LLC

    Katy, Texas 77494
    United States

    Site Not Available

  • Houston Research Institute - Pasadena

    Pasadena, Texas 77505
    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

    Site Not Available

  • Velocity Clinical Research - Waco

    Waco, Texas 76710
    United States

    Site Not Available

  • American Research Corporation - Austin, TX

    Austin 4671654, Texas 4736286 78757
    United States

    Active - Recruiting

  • IMA Clinical Research - Austin, TX

    Austin 4671654, Texas 4736286 78745
    United States

    Active - Recruiting

  • Pinnacle Clinical Research - Austin, TX

    Austin 4671654, Texas 4736286 78757
    United States

    Active - Recruiting

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas 4684888, Texas 4736286 75203
    United States

    Active - Recruiting

  • Pinnacle Clinical Research - Georgetown

    Georgetown 4693342, Texas 4736286 78626
    United States

    Active - Recruiting

  • Baylor College of Medicine

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • Houston Research Institute

    Houston 4699066, Texas 4736286 77079
    United States

    Active - Recruiting

  • Houston Research Institute - Texas Medical Center

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

  • LinQ Research, LLC

    Katy 4702732, Texas 4736286 77494
    United States

    Active - Recruiting

  • Houston Research Institute - Pasadena

    Pasadena 4717782, Texas 4736286 77505
    United States

    Active - Recruiting

  • American Research Corporation - San Antonio

    San Antonio 4726206, Texas 4736286 78215
    United States

    Active - Recruiting

  • Pinnacle Clinical Research - San Antonio

    San Antonio 4726206, Texas 4736286 78229
    United States

    Active - Recruiting

  • Velocity Clinical Research - Waco

    Waco 4739526, Texas 4736286 76710
    United States

    Active - Recruiting

  • Richmond Institute for Veterans Research

    Richmond, Virginia 23249
    United States

    Site Not Available

  • Richmond Institute for Veterans Research

    Richmond 4781708, Virginia 6254928 23249
    United States

    Active - Recruiting

  • GI Alliance - Washington Gastroenterology

    Tacoma, Washington 98405
    United States

    Site Not Available

  • GI Alliance - Washington Gastroenterology

    Tacoma 5812944, Washington 5815135 98405
    United States

    Active - Recruiting

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