A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
NCT ID: NCT07221227
Last Updated: 2025-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1200 participants
INTERVENTIONAL
2025-10-23
2031-12-12
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Participants receiving dose level 1 of efimosfermin alfa
Efimosfermin alfa
Efimosfermin alfa will be administered
Participants receiving dose level 2 of efimosfermin alfa
Efimosfermin alfa
Efimosfermin alfa will be administered
Participants receiving Placebo
Placebo
Placebo will be administered
Interventions
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Efimosfermin alfa
Efimosfermin alfa will be administered
Efimosfermin alfa
Efimosfermin alfa will be administered
Placebo
Placebo will be administered
Eligibility Criteria
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Inclusion Criteria
2. Age \>=18 and \<=75 years at enrollment
3. History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition:
4. Liver biopsy confirmation of MASH consistent with stage F2 or F3 fibrosis and a NAS score \>=4 confirmed by a central pathologist
Exclusion Criteria
2. ALT or AST \>=5\*upper limit of normal (ULN)
3. Total bilirubin (BILI) \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total BILI of \>=1.3 mg/dL and direct BILI is \<=20% of total BILI; otherwise, the individual will be excluded.
4. Serum albumin \<=3.5 grams per deciliter (g/dL)
5. International normalized ratio (INR) \>=1.3 not due to therapeutic anticoagulation. Individuals receiving chronic anticoagulant treatment with higher INR values may be enrolled at the discretion of the Investigator and Study Medical Monitor.
6. Alkaline phosphatase (ALP) \>=2\*ULN
7. Platelet (PLT) count \<140,000 per (/) cubic millimeter (mm\^3); individuals with a PLT count between 110,000/mm\^3 and 140,000/mm\^3 may be enrolled after discussion with the Study Medical Monitor.
8. Serum creatinine \>=1.5 mg/dL or creatinine clearance \<=60 milliliter (mL)/minute (min)/1.73 square meter by Chronic Kidney Disease Epidemiology Collaboration equation
9. Alpha-fetoprotein \>=20 nanogram per milliliter (ng/mL)
10. Glycated hemoglobin \>=9.0%
11. Model for End-Stage Liver Disease score \>=12 unless the score is elevated in the absence of liver dysfunction (e.g., Gilbert's syndrome)
12. Phosphatidyl ethanol (PEth) \>=80 ng/mL at Screening
13. Known co-infection with any of the following:
1. Human immunodeficiency virus;
2. Hepatitis B virus;
3. Hepatitis C virus (HCV);
4. Hepatitis D virus; or
5. Hepatitis E virus.
14. Chronic liver disease from any other cause including, but not limited to, alcoholic liver disease; evidence of portal hypertension; viral hepatitis or any history or evidence of cirrhosis on screening liver biopsy; or decompensated liver disease such as clinical ascites, bleeding gastroesophageal varices, hepatorenal syndrome, or hepatic encephalopathy prior to Screening or Day 1.
15. Current or history of excessive alcohol intake for \>=3 months within the 12-month period prior to Screening
18 Years
75 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Miami, Florida, United States
Countries
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Central Contacts
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EU GSK Clinical Trials Call Center
Role: CONTACT
Phone: +44 (0) 20 89904466
Email: [email protected]
Facility Contacts
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US GSK Clinical Trials Call Center
Role: primary
EU GSK Clinical Trials Call Centre
Role: backup
Other Identifiers
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2025-523675-39
Identifier Type: OTHER
Identifier Source: secondary_id
301160
Identifier Type: -
Identifier Source: org_study_id