Actively Recruiting
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Led by GlaxoSmithKline · Updated on 2026-04-16
1200
Participants Needed
49
Research Sites
320 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and biopsy-confirmed F2- or F3-stage fibrosis.
CONDITIONS
Official Title
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to understand and sign a written informed consent form before study procedures
- Age between 18 and 75 years at enrollment
- History or presence of two or more of the five components of metabolic syndrome according to the American Heart Association
- Liver biopsy confirming MASH with stage F2 or F3 fibrosis and a NAS score of 4 or higher, confirmed by a central pathologist
You will not qualify if you...
- Contraindication or inability to undergo percutaneous liver biopsy
- ALT or AST levels five times or more above the upper limit of normal
- Total bilirubin level 1.3 mg/dL or higher, except for Gilbert's syndrome cases with isolated bilirubin increase and low direct bilirubin
- Serum albumin level 3.5 g/dL or lower
- INR 1.3 or higher not caused by anticoagulation therapy (exceptions possible with medical approval)
- Alkaline phosphatase level twice or more above the upper limit of normal
- Platelet count below 140,000/mm3 (counts between 110,000/mm3 and 140,000/mm3 may be considered after medical review)
- Serum creatinine 1.5 mg/dL or higher or creatinine clearance 60 mL/min/1.73 m2 or lower
- Alpha-fetoprotein level 20 ng/mL or higher
- Glycated hemoglobin 9.0% or higher
- Model for End-Stage Liver Disease score 12 or higher unless due to non-liver causes
- Phosphatidyl ethanol level 80 ng/mL or higher at screening
- Infection with HIV, hepatitis B (detectable HBsAg), or hepatitis C
- Chronic liver diseases other than MASH, including alcoholic liver disease, portal hypertension, viral hepatitis, cirrhosis, or decompensated liver disease
- Current or history of excessive alcohol use for 3 months or more within the past 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
GSK Investigational Site
Arcadia, California, United States, 91006
Actively Recruiting
2
GSK Investigational Site
Covina, California, United States, 91723
Actively Recruiting
3
GSK Investigational Site
Los Angeles, California, United States, 90057
Actively Recruiting
4
GSK Investigational Site
Santa Maria, California, United States, 93458
Actively Recruiting
5
GSK Investigational Site
Van Nuys, California, United States, 91405
Actively Recruiting
6
GSK Investigational Site
Boynton Beach, Florida, United States, 33435
Actively Recruiting
7
GSK Investigational Site
Cape Coral, Florida, United States, 33914
Actively Recruiting
8
GSK Investigational Site
Hialeah, Florida, United States, 33016
Actively Recruiting
9
GSK Investigational Site
Hialeah, Florida, United States, 33016
Actively Recruiting
10
GSK Investigational Site
Inverness, Florida, United States, 34452
Actively Recruiting
11
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Actively Recruiting
12
GSK Investigational Site
Kissimmee, Florida, United States, 34744
Actively Recruiting
13
GSK Investigational Site
Lakeland, Florida, United States, 33803
Actively Recruiting
14
GSK Investigational Site
Maitland, Florida, United States, 32751
Actively Recruiting
15
GSK Investigational Site
Miami, Florida, United States, 33135
Actively Recruiting
16
GSK Investigational Site
Miami, Florida, United States, 33144
Actively Recruiting
17
GSK Investigational Site
Miami, Florida, United States, 33155
Actively Recruiting
18
GSK Investigational Site
Miami, Florida, United States, 33156
Actively Recruiting
19
GSK Investigational Site
Miami, Florida, United States, 33184
Actively Recruiting
20
GSK Investigational Site
Miami Lakes, Florida, United States, 33014
Actively Recruiting
21
GSK Investigational Site
Ocala, Florida, United States, 34471
Actively Recruiting
22
GSK Investigational Site
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
23
GSK Investigational Site
Topeka, Kansas, United States, 66606
Actively Recruiting
24
GSK Investigational Site
Springfield, Missouri, United States, 62703
Actively Recruiting
25
GSK Investigational Site
St Louis, Missouri, United States, 63141
Actively Recruiting
26
GSK Investigational Site
East Syracuse, New York, United States, 13057
Actively Recruiting
27
GSK Investigational Site
New York, New York, United States, 10036
Actively Recruiting
28
GSK Investigational Site
New York, New York, United States, 10036
Actively Recruiting
29
GSK Investigational Site
Morehead City, North Carolina, United States, 28557
Actively Recruiting
30
GSK Investigational Site
Akron, Ohio, United States, 44320
Actively Recruiting
31
GSK Investigational Site
Springboro, Ohio, United States, 45066
Actively Recruiting
32
GSK Investigational Site
Chattanooga, Tennessee, United States, 37421
Actively Recruiting
33
GSK Investigational Site
Austin, Texas, United States, 78704
Actively Recruiting
34
GSK Investigational Site
Austin, Texas, United States, 78759
Actively Recruiting
35
GSK Investigational Site
Bellaire, Texas, United States, 77401
Actively Recruiting
36
GSK Investigational Site
Brownsville, Texas, United States, 78526
Actively Recruiting
37
GSK Investigational Site
Dallas, Texas, United States, 75243
Actively Recruiting
38
GSK Investigational Site
DeSoto, Texas, United States, 75115
Actively Recruiting
39
GSK Investigational Site
Richmond, Texas, United States, 77406
Actively Recruiting
40
GSK Investigational Site
San Antonio, Texas, United States, 78215
Actively Recruiting
41
GSK Investigational Site
San Antonio, Texas, United States, 78229
Actively Recruiting
42
GSK Investigational Site
Seabrook, Texas, United States, 77586
Actively Recruiting
43
GSK Investigational Site
Sugar Land, Texas, United States, 77479
Actively Recruiting
44
GSK Investigational Site
Tomball, Texas, United States, 77375
Actively Recruiting
45
GSK Investigational Site
Waco, Texas, United States, 76710
Actively Recruiting
46
GSK Investigational Site
Waco, Texas, United States, 76712
Actively Recruiting
47
GSK Investigational Site
West Jordan, Utah, United States, 84088
Actively Recruiting
48
GSK Investigational Site
Manassas, Virginia, United States, 20110
Actively Recruiting
49
GSK Investigational Site
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
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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