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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

2026-01-21

Healthy Volunteers

No

Interventions

DRUG

Efimosfermin Alfa

Efimosfermin Alfa will be administered

DRUG

Placebo

Placebo will be administered

Locations (6)

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Waco, Texas, United States