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

NCT06920043 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 306301 (BOS-580-202)
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 35

Brief 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.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

Keywords

Fibroblast growth factor; Stage 4 fibrosis; Compensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment emergent adverse events (TEAEs)

  To assess the effects of efimosfermin on safety and tolerability.

  From Day 1 to 100 weeks

Secondary Outcomes (5)

• Serum concentrations of efimosfermin

  Up to Week 21

• Maximum serum drug concentration (Cmax) of efimosfermin

  Up to Week 21

• Area under the serum concentration-time curve (AUC) of efimosfermin

  Up to Week 21

• Average serum drug concentration (Cavg) of efimosfermin

  Up to Week 21

• Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin

  Up to Week 21

Study Arms (3)

Efimosfermin (Dose 1)

EXPERIMENTAL

Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).

Drug: Efimosfermin

Efimosfermin (Dose 2)

EXPERIMENTAL

Participants will receive efimosfermin (Dose 2) Q4W.

Drug: Efimosfermin

Placebo

PLACEBO COMPARATOR

Participants will receive placebo Q4W.

Drug: Placebo

Interventions

Placebo DRUG

Placebo will be administered as a subcutaneous injection.

Placebo

Efimosfermin DRUG

Efimosfermin will be administered as a subcutaneous injection.

Also known as: BOS-580

Efimosfermin (Dose 1); Efimosfermin (Dose 2)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boston Pharmaceuticals: lead
• GlaxoSmithKline: collaborator

Study Sites (35)

Arizona Liver Health - Chandler

Chandler, Arizona, 85224, United States

RECRUITING

Arizona Liver Health - Peoria

Peoria, Arizona, 85381, United States

RECRUITING

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

Tucson, Arizona, 85712, United States

RECRUITING

Fresno Clinical Research Center

Fresno, California, 93720, United States

RECRUITING

OM Research LLC

Lancaster, California, 93534, United States

RECRUITING

Knowledge Research Center

Orange, California, 92868, United States

RECRUITING

California Liver Research Institute

Pasadena, California, 91105, United States

RECRUITING

Inland Empire Liver Foundation

Rialto, California, 92377, United States

RECRUITING

Santa Maria Gastroenterology Center

Santa Maria, California, 93458, United States

RECRUITING

ClinCloud Research - Maitland

Maitland, Florida, 32751, United States

WITHDRAWN

ClinCloud Research - Viera

Melbourne, Florida, 32940, United States

RECRUITING

Advanced Clinical Research of Miami

Miami, Florida, 33155, United States

RECRUITING

Centricity Research - Columbus

Columbus, Georgia, 31904, United States

RECRUITING

Gastrointestinal Specialists of Georgia PC

Marietta, Georgia, 30060, United States

RECRUITING

Mercy Medical Center - Baltimore, Maryland

Baltimore, Maryland, 21202, United States

RECRUITING

Gastrointestinal Associates and Endoscopy Center, PA - Flowood

Flowood, Mississippi, 39232, United States

RECRUITING

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Coastal Research Institute, LLC

Fayetteville, North Carolina, 28304, United States

RECRUITING

M3 Wake Research, Inc

Raleigh, North Carolina, 27612, United States

RECRUITING

IMA Clinical Research - Austin, TX

Austin, Texas, 78745, United States

RECRUITING

American Research Corporation - Austin, TX

Austin, Texas, 78757, United States

RECRUITING

Pinnacle Clinical Research - Austin, TX

Austin, Texas, 78757, United States

RECRUITING

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States

RECRUITING

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, 78626, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

RECRUITING

Houston Research Institute - Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

Houston Research Institute

Houston, Texas, 77079, United States

RECRUITING

LinQ Research, LLC

Katy, Texas, 77494, United States

RECRUITING

Houston Research Institute - Pasadena

Pasadena, Texas, 77505, United States

RECRUITING

American Research Corporation - San Antonio

San Antonio, Texas, 78215, United States

RECRUITING

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Velocity Clinical Research - Waco

Waco, Texas, 76710, United States

RECRUITING

Richmond Institute for Veterans Research

Richmond, Virginia, 23249, United States

RECRUITING

GI Alliance - Washington Gastroenterology

Tacoma, Washington, 98405, United States

RECRUITING

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Patricia Mendez, MD

CONTACT

617-826-0300; patricia.mendez@bostonpharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 9, 2025
• Study Start: April 9, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (35)