RecruitingPhase 2NCT06920043

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

A Phase 2, Randomized, Double-blinded, Placebo-controlled Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

Sponsor

Boston Pharmaceuticals

Enrollment

42 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Efimosfermin and a drug called Placebo for people with metabolic dysfunction-associated steatohepatitis. The study is currently recruiting participants at 35 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEfimosfermin

Efimosfermin will be administered as a subcutaneous injection.

DRUGPlacebo

Placebo will be administered as a subcutaneous injection.

Locations(35)

Arizona Liver Health - Chandler

Chandler, Arizona, United States

Arizona Liver Health - Peoria

Peoria, Arizona, United States

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

Tucson, Arizona, United States

Fresno Clinical Research Center

Fresno, California, United States

OM Research LLC

Lancaster, California, United States

Knowledge Research Center

Orange, California, United States

California Liver Research Institute

Pasadena, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

Santa Maria Gastroenterology Center

Santa Maria, California, United States

ClinCloud Research - Maitland

Maitland, Florida, United States

ClinCloud Research - Viera

Melbourne, Florida, United States

Advanced Clinical Research of Miami

Miami, Florida, United States

Centricity Research - Columbus

Columbus, Georgia, United States

Gastrointestinal Specialists of Georgia PC

Marietta, Georgia, United States

Mercy Medical Center - Baltimore, Maryland

Baltimore, Maryland, United States

Gastrointestinal Associates and Endoscopy Center, PA - Flowood

Flowood, Mississippi, United States

Kansas City Research Institute

Kansas City, Missouri, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Coastal Research Institute, LLC

Fayetteville, North Carolina, United States

M3 Wake Research, Inc

Raleigh, North Carolina, United States

IMA Clinical Research - Austin, TX

Austin, Texas, United States

American Research Corporation - Austin, TX

Austin, Texas, United States

Pinnacle Clinical Research - Austin, TX

Austin, Texas, United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Research Institute - Texas Medical Center

Houston, Texas, United States

Houston Research Institute

Houston, Texas, United States

LinQ Research, LLC

Katy, Texas, United States

Houston Research Institute - Pasadena

Pasadena, Texas, United States

American Research Corporation - San Antonio

San Antonio, Texas, United States

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, United States

Velocity Clinical Research - Waco

Waco, Texas, United States

Richmond Institute for Veterans Research

Richmond, Virginia, United States

GI Alliance - Washington Gastroenterology

Tacoma, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06920043

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