Actively Recruiting
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
Led by GlaxoSmithKline · Updated on 2026-04-16
1250
Participants Needed
43
Research Sites
119 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
CONDITIONS
Official Title
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected 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 prior to starting study procedures
- Age 18 through 75 years at enrollment
- History or presence of two or more of the five components of metabolic syndrome as defined by the American Heart Association
- History or presence of known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with evidence of fibrosis
You will not qualify if you...
- ALT or AST levels equal to or greater than five times the upper limit of normal
- Total bilirubin equal to or greater than 1.3 mg/dL unless isolated increase due to Gilbert's syndrome with direct bilirubin 20% or less of total
- Serum albumin 3.5 grams per deciliter or lower
- International normalized ratio (INR) equal to or greater than 1.3 unless due to therapeutic anticoagulation
- Alkaline phosphatase equal to or greater than two times the upper limit of normal
- Platelet count below 140,000 per cubic millimeter, with possible enrollment if between 110,000 and 140,000 after medical review
- Serum creatinine equal to or greater than 1.5 mg/dL or creatinine clearance 60 mL/min/1.73 m2 or less
- Alpha-fetoprotein equal to or greater than 20 ng/mL
- HbA1c equal to or greater than 9.0%
- Model for End-Stage Liver Disease (MELD) score 12 or higher unless elevated without liver dysfunction
- Phosphatidylethanol (PEth) equal to or greater than 80 ng/mL at screening
- Known co-infection with HIV, Hepatitis B, C, D, or E viruses
- Chronic liver disease from other causes including alcoholic liver disease, portal hypertension, viral hepatitis, cirrhosis, or decompensated liver disease
- Current or history of excessive alcohol intake for 3 months or more within the 12 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 43 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
Cape Coral, Florida, United States, 33914
Actively Recruiting
6
GSK Investigational Site
Doral, Florida, United States, 33016
Actively Recruiting
7
GSK Investigational Site
Hialeah, Florida, United States, 33016
Actively Recruiting
8
GSK Investigational Site
Inverness, Florida, United States, 34452
Actively Recruiting
9
GSK Investigational Site
Jacksonville, Florida, United States, 32216
Actively Recruiting
10
GSK Investigational Site
Kissimmee, Florida, United States, 34744
Actively Recruiting
11
GSK Investigational Site
Lakeland, Florida, United States, 33803
Actively Recruiting
12
GSK Investigational Site
Maitland, Florida, United States, 32751
Actively Recruiting
13
GSK Investigational Site
Miami, Florida, United States, 33135
Actively Recruiting
14
GSK Investigational Site
Miami, Florida, United States, 33155
Actively Recruiting
15
GSK Investigational Site
Miami, Florida, United States, 33156
Actively Recruiting
16
GSK Investigational Site
Miami, Florida, United States, 33184
Actively Recruiting
17
GSK Investigational Site
Miami Lakes, Florida, United States, 33014
Actively Recruiting
18
GSK Investigational Site
Ocala, Florida, United States, 34471
Actively Recruiting
19
GSK Investigational Site
Palmetto Bay, Florida, United States, 33157
Actively Recruiting
20
GSK Investigational Site
Topeka, Kansas, United States, 66606
Actively Recruiting
21
GSK Investigational Site
Springfield, Missouri, United States, 62703
Actively Recruiting
22
GSK Investigational Site
St Louis, Missouri, United States, 63141
Actively Recruiting
23
GSK Investigational Site
Jersey City, New Jersey, United States, 07059
Actively Recruiting
24
GSK Investigational Site
East Syracuse, New York, United States, 13057
Actively Recruiting
25
GSK Investigational Site
New York, New York, United States, 10036
Actively Recruiting
26
GSK Investigational Site
Morehead City, North Carolina, United States, 28557
Actively Recruiting
27
GSK Investigational Site
Akron, Ohio, United States, 44320
Actively Recruiting
28
GSK Investigational Site
Springboro, Ohio, United States, 45066
Actively Recruiting
29
GSK Investigational Site
Austin, Texas, United States, 78745
Actively Recruiting
30
GSK Investigational Site
Austin, Texas, United States, 78759
Actively Recruiting
31
GSK Investigational Site
Brownsville, Texas, United States, 78526
Actively Recruiting
32
GSK Investigational Site
Dallas, Texas, United States, 75243
Actively Recruiting
33
GSK Investigational Site
DeSoto, Texas, United States, 75115
Actively Recruiting
34
GSK Investigational Site
Richmond, Texas, United States, 77406
Actively Recruiting
35
GSK Investigational Site
San Antonio, Texas, United States, 78215
Actively Recruiting
36
GSK Investigational Site
San Antonio, Texas, United States, 78229
Actively Recruiting
37
GSK Investigational Site
Seabrook, Texas, United States, 77586
Actively Recruiting
38
GSK Investigational Site
Tomball, Texas, United States, 77375
Actively Recruiting
39
GSK Investigational Site
Waco, Texas, United States, 76710
Actively Recruiting
40
GSK Investigational Site
Waco, Texas, United States, 76712
Actively Recruiting
41
GSK Investigational Site
West Jordan, Utah, United States, 84088
Actively Recruiting
42
GSK Investigational Site
Manassas, Virginia, United States, 20110
Actively Recruiting
43
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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