Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Efficacy of Efimosfermin Alfa in Participants With Biopsy-Confirmed F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Led by GlaxoSmithKline · Updated on 2026-04-16
1200
Participants Needed
49
Research Sites
193 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of efimosfermin alfa in people with metabolic dysfunction-associated steatohepatitis (MASH) who have biopsy-confirmed liver fibrosis at stage F2 or F3. This Phase 3, randomized, double-blind, placebo-controlled study aims to compare efimosfermin alfa to placebo in improving liver-related outcomes and resolving steatohepatitis over a long-term period. Participants will be randomly assigned to one of three groups: two different dose levels of efimosfermin alfa or a placebo group. The study treatment will be administered under medical supervision, and the trial includes multiple assessments at baseline, Week 52, and Month 48. The study will measure liver fibrosis improvement, steatohepatitis resolution, and liver-related clinical outcomes, among other key health indicators. During the study, participants will undergo liver biopsies, blood tests, imaging scans, and questionnaires to monitor liver health and treatment effects. Researchers will track clinical outcomes for up to 48 months from the start of treatment. Safety will be closely monitored through adverse event reporting and laboratory tests. Participants are expected to attend regular visits for evaluations and follow-up throughout the study duration.
CONDITIONS
Brief 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 give written informed consent before starting study procedures
- Age 18 to 75 years at enrollment
- History or presence of two or more metabolic syndrome components as defined by the American Heart Association
- Liver biopsy confirming MASH with stage F2 or F3 fibrosis and a NAS score of 4 or higher as confirmed by a central pathologist
You will not qualify if you...
- Contraindication or inability to undergo percutaneous liver biopsy
- ALT or AST levels 5 times or more above the upper limit of normal
- Total bilirubin 1.3 mg/dL or higher except for Gilbert's syndrome with specific criteria
- Serum albumin 3.5 g/dL or less
- INR 1.3 or higher not due to anticoagulation therapy, with some exceptions
- Alkaline phosphatase 2 times or more above the upper limit of normal
- Platelet count below 140,000/mm3, with possible exceptions after medical discussion
- Serum creatinine 1.5 mg/dL or higher or creatinine clearance 60 mL/min/1.73 m2 or less
- Alpha-fetoprotein 20 ng/mL or higher
- Glycated hemoglobin 9.0% or higher
- Model for End-Stage Liver Disease score 12 or higher unless elevated due to non-liver dysfunction
- Phosphatidyl ethanol 80 ng/mL or higher at screening
- Infection with HIV, hepatitis B, or hepatitis C
- Chronic liver disease from other causes including alcoholic liver disease, cirrhosis, portal hypertension, or decompensated liver disease
- Current or recent history of excessive alcohol use within 12 months prior to screening
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 - 52 weeks
Participants receive efimosfermin alfa or placebo to investigate safety and efficacy for metabolic dysfunction-associated steatohepatitis.
Regular visits during treatment period
Duration - Up to 48 months
Participants are monitored for up to 48 months to assess long-term safety and efficacy outcomes after treatment.
Periodic visits up to 48 months
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
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6
GSK Investigational Site
Boynton Beach, Florida, United States, 33435
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7
GSK Investigational Site
Cape Coral, Florida, United States, 33914
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8
GSK Investigational Site
Hialeah, Florida, United States, 33016
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9
GSK Investigational Site
Hialeah, Florida, United States, 33016
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10
GSK Investigational Site
Inverness, Florida, United States, 34452
Actively Recruiting
11
GSK Investigational Site
Jacksonville, Florida, United States, 32216
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12
GSK Investigational Site
Kissimmee, Florida, United States, 34744
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13
GSK Investigational Site
Lakeland, Florida, United States, 33803
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14
GSK Investigational Site
Maitland, Florida, United States, 32751
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15
GSK Investigational Site
Miami, Florida, United States, 33135
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16
GSK Investigational Site
Miami, Florida, United States, 33144
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17
GSK Investigational Site
Miami, Florida, United States, 33155
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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
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21
GSK Investigational Site
Ocala, Florida, United States, 34471
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22
GSK Investigational Site
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
23
GSK Investigational Site
Topeka, Kansas, United States, 66606
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24
GSK Investigational Site
Springfield, Missouri, United States, 62703
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25
GSK Investigational Site
St Louis, Missouri, United States, 63141
Actively Recruiting
26
GSK Investigational Site
East Syracuse, New York, United States, 13057
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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
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39
GSK Investigational Site
Richmond, Texas, United States, 77406
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40
GSK Investigational Site
San Antonio, Texas, United States, 78215
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41
GSK Investigational Site
San Antonio, Texas, United States, 78229
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42
GSK Investigational Site
Seabrook, Texas, United States, 77586
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43
GSK Investigational Site
Sugar Land, Texas, United States, 77479
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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
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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
E
EU GSK Clinical Trials Call Center
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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