NCT07221188

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Efimosfermin Alfa	Efimosfermin Alfa will be administered
DRUG	Placebo	Placebo will be administered

Timeline

• Start date: 2025-12-12
• Primary completion: 2028-03-24
• Completion: 2028-03-24
• First posted: 2025-10-27
• Last updated: 2026-04-16

Locations

43 sites across 1 country: United States

Regulatory

• FDA-regulated drug study