RecruitingPhase 3NCT07221227

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)

Sponsor

GlaxoSmithKline

Enrollment

1,200 participants

Start Date

Oct 24, 2025

Study Type

INTERVENTIONAL

Conditions

Non-Alcoholic Fatty Liver Disease

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Efimosfermin alfa, a drug called Efimosfermin alfa, and others for people with non-alcoholic fatty liver disease. The study is currently recruiting participants at 49 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEfimosfermin alfa

Efimosfermin alfa will be administered

DRUGEfimosfermin alfa

Efimosfermin alfa will be administered

DRUGPlacebo

Placebo will be administered

Locations(91)

GSK Investigational Site

Chandler, Arizona, United States

GSK Investigational Site

Tucson, Arizona, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Arcadia, California, United States

GSK Investigational Site

Covina, California, United States

GSK Investigational Site

Folsom, California, United States

GSK Investigational Site

Los Angeles, California, United States

GSK Investigational Site

Montclair, California, United States

GSK Investigational Site

Riverdale, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Santa Maria, California, United States

GSK Investigational Site

Van Nuys, California, United States

GSK Investigational Site

Colorado Springs, Colorado, United States

GSK Investigational Site

Boynton Beach, Florida, United States

GSK Investigational Site

Cape Coral, Florida, United States

GSK Investigational Site

Clermont, Florida, United States

GSK Investigational Site

Fort Myers, Florida, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Hialeah, Florida, United States

GSK Investigational Site

Homestead, Florida, United States

GSK Investigational Site

Inverness, Florida, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Kissimmee, Florida, United States

GSK Investigational Site

Lakeland, Florida, United States

GSK Investigational Site

Maitland, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

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

GSK Investigational Site

Bastrop, Louisiana, United States

GSK Investigational Site

Marrero, Louisiana, United States

GSK Investigational Site

Kansas City, Missouri, United States

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Springfield, Missouri, United States

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St Louis, Missouri, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

East Syracuse, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

New York, New York, United States

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Fayetteville, North Carolina, United States

GSK Investigational Site

Morehead City, North Carolina, United States

GSK Investigational Site

Akron, Ohio, United States

GSK Investigational Site

Springboro, Ohio, United States

GSK Investigational Site

Westlake, Ohio, United States

GSK Investigational Site

Chattanooga, Tennessee, United States

GSK Investigational Site

Arlington, Texas, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Bellaire, Texas, United States

GSK Investigational Site

Brownsville, Texas, United States

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Dallas, Texas, United States

GSK Investigational Site

DeSoto, Texas, United States

GSK Investigational Site

Houston, Texas, United States

GSK Investigational Site

Irving, Texas, United States

GSK Investigational Site

Richmond, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Seabrook, Texas, United States

GSK Investigational Site

Sugar Land, Texas, United States

GSK Investigational Site

Tomball, Texas, United States

GSK Investigational Site

Waco, Texas, United States

GSK Investigational Site

Waco, Texas, United States

GSK Investigational Site

West Jordan, Utah, United States

GSK Investigational Site

Manassas, Virginia, United States

GSK Investigational Site

Norfolk, Virginia, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Broadmeadow, New South Wales, Australia

GSK Investigational Site

Heidelberg, Victoria, Australia

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Pokfulam, Hong Kong

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Musashino, Japan

GSK Investigational Site

Yokohama, Japan

GSK Investigational Site

Wellington, New Zealand

GSK Investigational Site

San Juan, Puerto Rico

GSK Investigational Site

Riyadh, Saudi Arabia

GSK Investigational Site

Chiayi City, Taiwan

GSK Investigational Site

Kaohsiung City, Taiwan

GSK Investigational Site

Kaohsiung City, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07221227

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