RecruitingPhase 3NCT07221188

A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)

Sponsor

GlaxoSmithKline

Enrollment

1,250 participants

Start Date

Dec 12, 2025

Study Type

INTERVENTIONAL

Conditions

Non-Alcoholic Fatty Liver Disease

Summary

This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.

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 and a drug called Placebo for people with non-alcoholic fatty liver disease. The study is currently recruiting participants at 43 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

DRUGPlacebo

Placebo will be administered

Locations(53)

GSK Investigational Site

Arcadia, California, United States

GSK Investigational Site

Covina, California, United States

GSK Investigational Site

Los Angeles, 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

Boynton Beach, Florida, United States

GSK Investigational Site

Cape Coral, Florida, United States

GSK Investigational Site

Doral, 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 Lakes, Florida, United States

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

Palmetto Bay, Florida, United States

GSK Investigational Site

Sarasota, Florida, United States

GSK Investigational Site

Topeka, Kansas, United States

GSK Investigational Site

Marrero, Louisiana, United States

GSK Investigational Site

Springfield, Missouri, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Jersey City, New Jersey, United States

GSK Investigational Site

East Syracuse, New York, United States

GSK Investigational Site

New York, New York, 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

Chattanooga, Tennessee, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Brownsville, Texas, United States

GSK Investigational Site

Dallas, Texas, United States

GSK Investigational Site

DeSoto, 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

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

Seattle, Washington, United States

GSK Investigational Site

Pokfulam, Hong Kong

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NCT07221188

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