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
Location: See all (43) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Able and willing to understand and sign a written informed consent form (ICF) that must be obtained prior to the initiation of study procedures
• Age \>=18 through \<=75 years at enrolment
• History or presence of 2 or more of the 5 components of metabolic syndrome per American Heart Association definition
• History or presence of known or suspected MASH with evidence of fibrosis
Locations
United States
California
GSK Investigational Site
RECRUITING
Arcadia
GSK Investigational Site
RECRUITING
Covina
GSK Investigational Site
RECRUITING
Los Angeles
GSK Investigational Site
RECRUITING
Santa Maria
Florida
GSK Investigational Site
RECRUITING
Cape Coral
GSK Investigational Site
RECRUITING
Doral
GSK Investigational Site
RECRUITING
Hialeah
GSK Investigational Site
RECRUITING
Inverness
GSK Investigational Site
RECRUITING
Jacksonville
GSK Investigational Site
RECRUITING
Kissimmee
GSK Investigational Site
RECRUITING
Lakeland
GSK Investigational Site
RECRUITING
Maitland
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Miami
GSK Investigational Site
RECRUITING
Miami Lakes
GSK Investigational Site
RECRUITING
Ocala
GSK Investigational Site
RECRUITING
Palmetto Bay
Kansas
GSK Investigational Site
RECRUITING
Topeka
Missouri
GSK Investigational Site
RECRUITING
Springfield
GSK Investigational Site
RECRUITING
St Louis
North Carolina
GSK Investigational Site
RECRUITING
Morehead City
New Jersey
GSK Investigational Site
RECRUITING
Jersey City
New York
GSK Investigational Site
RECRUITING
East Syracuse
GSK Investigational Site
RECRUITING
New York
Ohio
GSK Investigational Site
RECRUITING
Akron
GSK Investigational Site
RECRUITING
Springboro
Texas
GSK Investigational Site
RECRUITING
Austin
GSK Investigational Site
RECRUITING
Austin
GSK Investigational Site
RECRUITING
Brownsville
GSK Investigational Site
RECRUITING
Dallas
GSK Investigational Site
RECRUITING
Desoto
GSK Investigational Site
RECRUITING
Richmond
GSK Investigational Site
RECRUITING
San Antonio
GSK Investigational Site
RECRUITING
San Antonio
GSK Investigational Site
RECRUITING
Seabrook
GSK Investigational Site
RECRUITING
Tomball
GSK Investigational Site
RECRUITING
Waco
GSK Investigational Site
RECRUITING
Waco
Utah
GSK Investigational Site
RECRUITING
West Jordan
Virginia
GSK Investigational Site
RECRUITING
Manassas
Washington
GSK Investigational Site
RECRUITING
Seattle
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2028-03-24
Participants
Target number of participants: 1250
Treatments
Experimental: Efimosfermin Alfa Dose Level 1
Participants randomized to this group will receive Efimosfermin Alfa at dose level 1
Experimental: Efimosfermin Alfa Dose Level 2
Participants randomized to this group will receive Efimosfermin Alfa at dose level 2
Placebo_comparator: Placebo
Participants randomized to this group will receive Placebo
Related Therapeutic Areas
Sponsors
Leads: GlaxoSmithKline