Zenith 2
Research type
Research Study
Full 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)
IRAS ID
1013370
Contact name
Derek Moriarty
Contact email
Sponsor organisation
GSK Research & Development Limited
ISRCTN Number
ISRCTN34498249
Clinicaltrials.gov Identifier
Research summary
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, 52-week study of the safety and tolerability of efimosfermin administered every 4 weeks (Q4W) by subcutaneous (SC) injection in adult participants with known or suspected MASH with fibrosis consistent with stage F2 or F3. The total time of participation in the study, inclusive of Screening and safety follow-up, is approximately 64 weeks.
The purpose of this study is to assess the safety and tolerability of monthly efimosfermin injections compared to placebo in individuals with known or suspected MASH with fibrosis consistent with F2- or F3-stage fibrosis following a maximum treatment duration of 52 weeks. Approximately 1250 participants will be randomized.
Participants will be enrolled and randomized 2:2:1 to receive 225 mg efimosfermin, 300 mg efimosfermin, or placebo Q4W by SC injection for a period of 52 weeks, followed by a final safety follow-up assessment at Week 56. Total time of participation in the study, inclusive of a Screening period of up to 8 weeks, is approximately 60 weeks. Since injection volumes for the 225-mg and 300-mg efimosfermin arms are 1.5 mL and 2.0 mL, respectively, additional measures will be implemented to preserve the study blind.
riteria are established in this protocol for dose interruption, modification, discontinuation, and resumption based on Investigator discretion and following consultation with the Study Medical Monitor (the Sponsor or designee) in specific circumstances.REC name
London - London Bridge Research Ethics Committee
REC reference
26/LO/0254
Date of REC Opinion
8 May 2026
REC opinion
Further Information Favourable Opinion