A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
NCT ID: NCT06920043
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
42 participants
INTERVENTIONAL
2025-04-09
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Efimosfermin (Dose 1)
Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).
Efimosfermin
Efimosfermin will be administered as a subcutaneous injection.
Efimosfermin (Dose 2)
Participants will receive efimosfermin (Dose 2) Q4W.
Efimosfermin
Efimosfermin will be administered as a subcutaneous injection.
Placebo
Participants will receive placebo Q4W.
Placebo
Placebo will be administered as a subcutaneous injection.
Interventions
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Efimosfermin
Efimosfermin will be administered as a subcutaneous injection.
Placebo
Placebo will be administered as a subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* History of type 1 diabetes
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Boston Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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306301 (BOS-580-202)
Identifier Type: -
Identifier Source: org_study_id