Actively Recruiting
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Tolerability of Efimosfermin Alfa in Adults With F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (ZENITH-2)
Led by GlaxoSmithKline · Updated on 2026-04-16
1250
Participants Needed
43
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of Efimosfermin Alfa in adults aged 18 to 75 years who have known or suspected metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis at stages F2 or F3. This phase 3, randomized, double-blind, placebo-controlled study aims to better understand how this drug affects participants with this liver condition related to metabolic syndrome components. Participants will be randomly assigned to one of three groups: one receiving Efimosfermin Alfa at dose level 1, another receiving Efimosfermin Alfa at dose level 2, and a third group receiving a placebo. The study will monitor the effects of these treatments over a period of 52 weeks, assessing safety and tolerability as well as changes in liver fibrosis markers and other related health measures. During the trial, participants will undergo regular assessments including laboratory tests, imaging scans such as MRI and elastography to measure liver stiffness and fat content, and blood tests to monitor liver enzymes and metabolic markers. Researchers will track treatment-emergent adverse events and laboratory abnormalities. The study involves continuous monitoring up to week 52 to evaluate changes from baseline and to ensure participant safety throughout the trial.
CONDITIONS
Brief 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 study procedures
- Age 18 through 75 years at enrollment
- History or presence of two or more 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...
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels 5 times or more above the upper limit of normal
- Total bilirubin (BILI) 1.3 mg/dL or higher, except for isolated increases due to Gilbert's syndrome
- Serum albumin 3.5 grams per deciliter or less
- International normalized ratio (INR) 1.3 or higher not due to anticoagulation therapy
- Alkaline phosphatase (ALP) 2 times or more above the upper limit of normal
- Platelet count less than 140,000/mm3, with possible exceptions after medical review
- Serum creatinine 1.5 mg/dL or higher or creatinine clearance 60 mL/min/1.73 m2 or less
- Alpha-fetoprotein 20 nanograms per milliliter or higher
- Hemoglobin A1c (HbA1c) 9.0% or higher
- Model for End-Stage Liver Disease (MELD) score 12 or higher unless due to non-liver dysfunction
- Phosphatidylethanol (PEth) 80 ng/mL or higher 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 recent excessive alcohol intake for 3 months or more within the past year
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 52 weeks
Participants receive Efimosfermin Alfa or placebo to evaluate safety and tolerability over the course of the study.
Regular visits throughout treatment period
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
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4
GSK Investigational Site
Santa Maria, California, United States, 93458
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5
GSK Investigational Site
Cape Coral, Florida, United States, 33914
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6
GSK Investigational Site
Doral, Florida, United States, 33016
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7
GSK Investigational Site
Hialeah, Florida, United States, 33016
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8
GSK Investigational Site
Inverness, Florida, United States, 34452
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9
GSK Investigational Site
Jacksonville, Florida, United States, 32216
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10
GSK Investigational Site
Kissimmee, Florida, United States, 34744
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11
GSK Investigational Site
Lakeland, Florida, United States, 33803
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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
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15
GSK Investigational Site
Miami, Florida, United States, 33156
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16
GSK Investigational Site
Miami, Florida, United States, 33184
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17
GSK Investigational Site
Miami Lakes, Florida, United States, 33014
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18
GSK Investigational Site
Ocala, Florida, United States, 34471
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19
GSK Investigational Site
Palmetto Bay, Florida, United States, 33157
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20
GSK Investigational Site
Topeka, Kansas, United States, 66606
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21
GSK Investigational Site
Springfield, Missouri, United States, 62703
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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
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29
GSK Investigational Site
Austin, Texas, United States, 78745
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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
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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
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36
GSK Investigational Site
San Antonio, Texas, United States, 78229
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37
GSK Investigational Site
Seabrook, Texas, United States, 77586
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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
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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
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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