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A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

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) (ZENITH-1)

NCT07221227•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able and willing to understand and sign a written informed consent form that must be obtained prior to the initiation of study procedures
•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

•1. Contraindication or ineligibility for percutaneous liver biopsy
•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%
+10 more criteria

Locations (1)

GSK Investigational Site

Miami, Florida, United States

Key Dates

Start Date

October 23, 2025

Primary Completion Date

March 29, 2028

Completion Date

December 12, 2031

Last Updated

October 31, 2025

Enrollment

1,200

ESTIMATED participants

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Efimosfermin alfa

DRUG

Efimosfermin alfa

DRUG

Placebo

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Identification of Liver Fibrosis Biomarkers

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RECRUITINGNA

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NCT06218589

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Inclusion Criteria

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

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