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

December 23, 2025 updated by: Boston Pharmaceuticals

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • Arizona Liver Health - Chandler
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • Arizona Liver Health - Peoria
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
    • California
      • Fresno, California, United States, 93720
        • Recruiting
        • Fresno Clinical Research Center
      • Lancaster, California, United States, 93534
        • Recruiting
        • OM Research LLC
      • Orange, California, United States, 92868
        • Recruiting
        • Knowledge Research Center
      • Pasadena, California, United States, 91105
        • Recruiting
        • California Liver Research Institute
      • Rialto, California, United States, 92377
        • Recruiting
        • Inland Empire Liver Foundation
      • Santa Maria, California, United States, 93458
        • Recruiting
        • Santa Maria Gastroenterology Center
    • Florida
      • Maitland, Florida, United States, 32751
        • Withdrawn
        • ClinCloud Research - Maitland
      • Melbourne, Florida, United States, 32940
        • Recruiting
        • ClinCloud Research - Viera
      • Miami, Florida, United States, 33155
        • Recruiting
        • Advanced Clinical Research of Miami
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Recruiting
        • Centricity Research - Columbus
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Gastrointestinal Specialists of Georgia PC
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center - Baltimore, Maryland
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Recruiting
        • Gastrointestinal Associates and Endoscopy Center, PA - Flowood
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Recruiting
        • Kansas City Research Institute
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai
    • North Carolina
      • Fayetteville, North Carolina, United States, 28304
        • Recruiting
        • Coastal Research Institute, LLC
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • M3 Wake Research, Inc
    • Texas
      • Austin, Texas, United States, 78757
        • Recruiting
        • American Research Corporation - Austin, TX
      • Austin, Texas, United States, 78745
        • Recruiting
        • IMA Clinical Research - Austin, TX
      • Austin, Texas, United States, 78757
        • Recruiting
        • Pinnacle Clinical Research - Austin, TX
      • Dallas, Texas, United States, 75203
        • Recruiting
        • The Liver Institute at Methodist Dallas Medical Center
      • Georgetown, Texas, United States, 78626
        • Recruiting
        • Pinnacle Clinical Research - Georgetown
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
      • Houston, Texas, United States, 77079
        • Recruiting
        • Houston Research Institute
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Research Institute - Texas Medical Center
      • Katy, Texas, United States, 77494
        • Recruiting
        • LinQ Research, LLC
      • Pasadena, Texas, United States, 77505
        • Recruiting
        • Houston Research Institute - Pasadena
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Pinnacle Clinical Research - San Antonio
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation - San Antonio
      • Waco, Texas, United States, 76710
        • Recruiting
        • Velocity Clinical Research - Waco
    • Virginia
      • Richmond, Virginia, United States, 23249
        • Recruiting
        • Richmond Institute for Veterans Research
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • GI Alliance - Washington Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Efimosfermin (Dose 1)
Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).
Drug: Efimosfermin
Efimosfermin will be administered as a subcutaneous injection.
Other Names:
  • BOS-580
Experimental: Efimosfermin (Dose 2)
Participants will receive efimosfermin (Dose 2) Q4W.
Drug: Efimosfermin
Efimosfermin will be administered as a subcutaneous injection.
Other Names:
  • BOS-580
Placebo Comparator: Placebo
Participants will receive placebo Q4W.
Drug: Placebo
Placebo will be administered as a subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment emergent adverse events (TEAEs)
Time Frame: From Day 1 to 100 weeks
To assess the effects of efimosfermin on safety and tolerability.
From Day 1 to 100 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentrations of efimosfermin
Time Frame: Up to Week 21
To assess the steady-state PK of efimosfermin.
Up to Week 21
Maximum serum drug concentration (Cmax) of efimosfermin
Time Frame: Up to Week 21
To assess the steady-state PK of efimosfermin.
Up to Week 21
Area under the serum concentration-time curve (AUC) of efimosfermin
Time Frame: Up to Week 21
To assess the steady-state PK of efimosfermin.
Up to Week 21
Average serum drug concentration (Cavg) of efimosfermin
Time Frame: Up to Week 21
To assess the steady-state PK of efimosfermin.
Up to Week 21
Concentration of study drug at the end of the dosing interval (Ctrough) of efimosfermin
Time Frame: Up to Week 21
To assess the steady-state PK of efimosfermin.
Up to Week 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Pharmaceuticals

Collaborators

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 26, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

December 24, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306301 (BOS-580-202)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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