Actively Recruiting
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)
Led by Boston Pharmaceuticals · Updated on 2025-12-24
42
Participants Needed
35
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Boston Pharmaceuticals
Lead Sponsor
G
GlaxoSmithKline
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying efimosfermin in people with metabolic dysfunction-associated steatohepatitis (MASH) who have compensated cirrhosis confirmed by liver biopsy with stage F4 fibrosis. The study aims to evaluate the safety, tolerability, early effectiveness, and how the body processes efimosfermin in this group. Participants will be randomly assigned to one of three groups: receiving either a lower dose or higher dose of efimosfermin or a placebo. All treatments are given by subcutaneous injection once every four weeks. This is a double-blind study, so neither participants nor researchers know which treatment is given to ensure unbiased results. During the study, participants will be monitored for up to 100 weeks to track any treatment-related side effects. Blood samples will be taken up to week 21 to measure efimosfermin levels and how the drug is processed in the body. Researchers will also keep track of safety and drug effects throughout the study period.
CONDITIONS
Brief Title
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign a written informed consent form
- 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
You will not qualify if you...
- 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 times the upper limit of normal
- Other exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 21 weeks
Participants receive efimosfermin or placebo as a subcutaneous injection once every 4 weeks.
Approximately 6 visits (in-person) for dosing and assessments
Duration - Up to 79 weeks after treatment
Participants are monitored for treatment emergent adverse events and ongoing safety up to 100 weeks after starting treatment.
Visit frequency not specified
Trial Site Locations
Total: 35 locations
1
Arizona Liver Health - Chandler
Chandler, Arizona, United States, 85224
Actively Recruiting
2
Arizona Liver Health - Peoria
Peoria, Arizona, United States, 85381
Actively Recruiting
3
The Institute for Liver Health II LLC dba Arizona Liver Health - Tucson
Tucson, Arizona, United States, 85712
Actively Recruiting
4
Fresno Clinical Research Center
Fresno, California, United States, 93720
Actively Recruiting
5
OM Research LLC
Lancaster, California, United States, 93534
Actively Recruiting
6
Knowledge Research Center
Orange, California, United States, 92868
Actively Recruiting
7
California Liver Research Institute
Pasadena, California, United States, 91105
Actively Recruiting
8
Inland Empire Liver Foundation
Rialto, California, United States, 92377
Actively Recruiting
9
Santa Maria Gastroenterology Center
Santa Maria, California, United States, 93458
Actively Recruiting
10
ClinCloud Research - Maitland
Maitland, Florida, United States, 32751
Withdrawn
11
ClinCloud Research - Viera
Melbourne, Florida, United States, 32940
Actively Recruiting
12
Advanced Clinical Research of Miami
Miami, Florida, United States, 33155
Actively Recruiting
13
Centricity Research - Columbus
Columbus, Georgia, United States, 31904
Actively Recruiting
14
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States, 30060
Actively Recruiting
15
Mercy Medical Center - Baltimore, Maryland
Baltimore, Maryland, United States, 21202
Actively Recruiting
16
Gastrointestinal Associates and Endoscopy Center, PA - Flowood
Flowood, Mississippi, United States, 39232
Actively Recruiting
17
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Actively Recruiting
18
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
19
Coastal Research Institute, LLC
Fayetteville, North Carolina, United States, 28304
Actively Recruiting
20
M3 Wake Research, Inc
Raleigh, North Carolina, United States, 27612
Actively Recruiting
21
IMA Clinical Research - Austin, TX
Austin, Texas, United States, 78745
Actively Recruiting
22
American Research Corporation - Austin, TX
Austin, Texas, United States, 78757
Actively Recruiting
23
Pinnacle Clinical Research - Austin, TX
Austin, Texas, United States, 78757
Actively Recruiting
24
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Actively Recruiting
25
Pinnacle Clinical Research - Georgetown
Georgetown, Texas, United States, 78626
Actively Recruiting
26
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
27
Houston Research Institute - Texas Medical Center
Houston, Texas, United States, 77030
Actively Recruiting
28
Houston Research Institute
Houston, Texas, United States, 77079
Actively Recruiting
29
LinQ Research, LLC
Katy, Texas, United States, 77494
Actively Recruiting
30
Houston Research Institute - Pasadena
Pasadena, Texas, United States, 77505
Actively Recruiting
31
American Research Corporation - San Antonio
San Antonio, Texas, United States, 78215
Actively Recruiting
32
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
33
Velocity Clinical Research - Waco
Waco, Texas, United States, 76710
Actively Recruiting
34
Richmond Institute for Veterans Research
Richmond, Virginia, United States, 23249
Actively Recruiting
35
GI Alliance - Washington Gastroenterology
Tacoma, Washington, United States, 98405
Actively Recruiting
Research Team
P
Patricia Mendez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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