Back to Trials
NCT06920043PHASE2Recruiting

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

Boston Pharmaceuticals

Start Date

4/9/2025

Completion Date

12/1/2027

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

Age Range: 18 years to 75 years

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.

Interventions

DRUG

Efimosfermin

DRUG

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

Locations

Arizona Liver Health - Chandler

Chandler, Arizona 85224

United States

Arizona Liver Health - Peoria

Peoria, Arizona 85381

United States

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

Tucson, Arizona 85712

United States

Fresno Clinical Research Center

Fresno, California 93720

United States

OM Research LLC

Lancaster, California 93534

United States

Knowledge Research Center

Orange, California 92868

United States

California Liver Research Institute

Pasadena, California 91105

United States

Inland Empire Liver Foundation

Rialto, California 92377

United States

Santa Maria Gastroenterology Center

Santa Maria, California 93458

United States

ClinCloud Research - Maitland

Maitland, Florida 32751

United States

ClinCloud Research - Viera

Melbourne, Florida 32940

United States

Advanced Clinical Research of Miami

Miami, Florida 33155

United States

Centricity Research - Columbus

Columbus, Georgia 31904

United States

Gastrointestinal Specialists of Georgia PC

Marietta, Georgia 30060

United States

Mercy Medical Center - Baltimore, Maryland

Baltimore, Maryland 21202

United States

Gastrointestinal Associates and Endoscopy Center, PA - Flowood

Flowood, Mississippi 39232

United States

Kansas City Research Institute

Kansas City, Missouri 64131

United States

Icahn School of Medicine at Mount Sinai

New York, New York 10029

United States

Coastal Research Institute, LLC

Fayetteville, North Carolina 28304

United States

M3 Wake Research, Inc

Raleigh, North Carolina 27612

United States

IMA Clinical Research - Austin, TX

Austin, Texas 78745

United States

American Research Corporation - Austin, TX

Austin, Texas 78757

United States

Pinnacle Clinical Research - Austin, TX

Austin, Texas 78757

United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas 75203

United States

Pinnacle Clinical Research - Georgetown

Georgetown, Texas 78626

United States

Baylor College of Medicine

Houston, Texas 77030

United States

Houston Research Institute - Texas Medical Center

Houston, Texas 77030

United States

Houston Research Institute

Houston, Texas 77079

United States

LinQ Research, LLC

Katy, Texas 77494

United States

Houston Research Institute - Pasadena

Pasadena, Texas 77505

United States

American Research Corporation - San Antonio

San Antonio, Texas 78215

United States

Pinnacle Clinical Research - San Antonio

San Antonio, Texas 78229

United States

Velocity Clinical Research - Waco

Waco, Texas 76710

United States

Richmond Institute for Veterans Research

Richmond, Virginia 23249

United States

GI Alliance - Washington Gastroenterology

Tacoma, Washington 98405

United States