A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)

Part of paid clinical trials in Miami, Florida.

Sponsor
GlaxoSmithKline
Study ID
NCT07704892
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Efimosfermin alfa — DRUG
    Efimosfermin alfa (subcutaneous injection) will be administered.
  • Placebo — DRUG
    Placebo (subcutaneous injection) will be administered.

Study Details

This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH. Participants who complete the treatment during Part A of the study and meet the inclusion criteria will have the option to enroll in Part B (open label) of the study.

Key Dates

First listed
Jul 15, 2026
Start date
Jul 22, 2026
Status verified
Aug 2026
Primary completion
Oct 16, 2030
Completion
Dec 8, 2033

Study Design

Enrollment
380 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Participants receiving Efimosfermin alfa
    Participants will receive efimosfermin alfa in Part A of the study.
  • Placebo Comparator: Part A: Participants receiving Placebo
    Participants will receive placebo in Part A of the study.
  • Experimental: Part B: Participants receiving Efimosfermin alfa
    All participants will receive efimosfermin alfa in Part B of the study.

Primary Outcome Measure

Part A: Proportion of participants achieving improvement in liver fibrosis by >=1 stage and no worsening of MASH [ Time Frame: At Week 96 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteMiamiFlorida33135
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Yaneicy Gonzalez Rojas (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteHoustonTexas77058
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Joe Pouzar (PRINCIPAL_INVESTIGATOR)

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