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RECRUITING

NCT07221227

PHASE3

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

Sponsor: 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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2025-10-24

Completion Date

2031-12-12

Last Updated

2026-07-27

Healthy Volunteers

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

DRUG

Efimosfermin alfa

Efimosfermin alfa will be administered

DRUG

Efimosfermin alfa

Efimosfermin alfa will be administered

DRUG

Placebo

Placebo will be administered

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 x upper limit of normal (ULN) 3. Total bilirubin \>=1.3 milligram per deciliter (mg/dL). Individuals with documented Gilbert's syndrome may be enrolled if they experienced an isolated increase in total bilirubin of \>=1.3 mg/dL and direct bilirubin is \<=20% of total bilirubin; 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. Evidence of infection with any of the following: 1. Human immunodeficiency virus; 2. Hepatitis B virus (detectable HBsAg at Screening); 3. Hepatitis C virus (HCV); 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

Locations (91)

GSK Investigational Site

Chandler, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Arcadia, California, United States

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Covina, California, United States

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Folsom, California, United States

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Los Angeles, California, United States

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Montclair, California, United States

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Riverdale, California, United States

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San Diego, California, United States

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Santa Maria, California, United States

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Van Nuys, California, United States

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Colorado Springs, Colorado, United States

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Boynton Beach, Florida, United States

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Cape Coral, Florida, United States

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Clermont, Florida, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Hialeah, Florida, United States

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Homestead, Florida, United States

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Inverness, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Lakeland, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Ocala, Florida, United States

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Palmetto Bay, Florida, United States

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Sarasota, Florida, United States

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Marietta, Georgia, United States

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Topeka, Kansas, United States

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Bastrop, Louisiana, United States

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Marrero, Louisiana, United States

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Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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East Syracuse, New York, United States

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New York, New York, United States

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New York, New York, United States

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Fayetteville, North Carolina, United States

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Morehead City, North Carolina, United States

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Akron, Ohio, United States

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Springboro, Ohio, United States

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Westlake, Ohio, United States

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Chattanooga, Tennessee, United States

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Arlington, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Austin, Texas, United States

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Bellaire, Texas, United States

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Brownsville, Texas, United States

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Dallas, Texas, United States

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DeSoto, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Richmond, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Seabrook, Texas, United States

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Sugar Land, Texas, United States

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Tomball, Texas, United States

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Waco, Texas, United States

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Waco, Texas, United States

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West Jordan, Utah, United States

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Manassas, Virginia, United States

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Norfolk, Virginia, United States

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Seattle, Washington, United States

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Broadmeadow, New South Wales, Australia

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Heidelberg, Victoria, Australia

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Québec, Quebec, Canada

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Pokfulam, Hong Kong

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Gifu, Japan

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Kanagawa, Japan

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Kyoto, Japan

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Musashino, Japan

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Yokohama, Japan

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Wellington, New Zealand

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San Juan, Puerto Rico

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Riyadh, Saudi Arabia

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Chiayi City, Taiwan

GSK Investigational Site

Kaohsiung City, Taiwan

GSK Investigational Site

Kaohsiung City, Taiwan

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (91)