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RECRUITING
NCT07221188
PHASE3

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

1250

Start Date

2025-12-12

Completion Date

2028-03-24

Last Updated

2026-04-16

Healthy Volunteers

No

Interventions

DRUG

Efimosfermin Alfa

Efimosfermin Alfa will be administered

DRUG

Placebo

Placebo will be administered

Locations (43)

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

Santa Maria, California, 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

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 Lakes, Florida, United States

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

Palmetto Bay, Florida, United States

GSK Investigational Site

Topeka, Kansas, 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

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

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