Recruiting

Phase 3

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

Sponsor:

GlaxoSmithKline

Code:

NCT07704892

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Efimosfermin alfa

Placebo

Study Details

Brief summary:

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.

Conditions

Metabolic Dysfunction-associated Steatohepatitis

Study ID

NCT07704892

Start date

Jul 22, 2026

Status verified date

Sep, 2026

Completion date

Dec 8, 2033

Anticipated

Primary completion date

Oct 16, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participants aged between 18 and 75 years at enrolment.
Participants with history or presence of at least two components of metabolic syndrome.
Liver biopsy consistent with cirrhosis (fibrosis stage 4).

Exclusion Criteria:

Participants with other chronic liver diseases.
Participants with evidence or history of decompensated liver disease or hepatocellular carcinoma.
Participants with history of Type 1 diabetes mellitus; or major Type 2 diabetes mellitus complications.
History or evidence of chronic pancreatic disease; pancreatic injury or acute pancreatitis within 6 months before Screening.
A recent history or planned surgical procedures or medications intended to produce significant weight loss.
Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >= 5 times upper limit normal (ULN).
Current or history of excessive alcohol intake

Study Design

Enrollment

380 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Efimosfermin alfa

Efimosfermin alfa (subcutaneous injection) will be administered.

Placebo

Placebo (subcutaneous injection) will be administered.

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 and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Little Rock, Arkansas, United States, 72211

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

John Baber

GSK Investigational Site

Recruiting

Folsom, California, United States, 95630

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Nazir Rahim

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33135-4661

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Yaneicy Gonzalez Rojas

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33155

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jorge Amaya

GSK Investigational Site

Recruiting

Ocala, Florida, United States, 34471

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Robert Barish

GSK Investigational Site

Recruiting

St Louis, Missouri, United States, 63141

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Brian Mcmorrow

GSK Investigational Site

Recruiting

New York, New York, United States, 10036-4103

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Eli Shalenberg

GSK Investigational Site

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Kathryn Lucas

GSK Investigational Site

Recruiting

Springboro, Ohio, United States, 45066

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Anjali Morey

GSK Investigational Site

Recruiting

Westlake, Ohio, United States, 44145-1493

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Naim Alkhouri

GSK Investigational Site

Recruiting

Arlington, Texas, United States, 76012

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Reem Ghalib

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78745-5675

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Nomita Kim

GSK Investigational Site

Recruiting

Bellaire, Texas, United States, 77401

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Everald Manning

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75243-1921

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Valentine Ebuh

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77058

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Joe Pouzar

GSK Investigational Site

Recruiting

Humble, Texas, United States, 77346

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Brian Chou

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78209

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Robert Morin Jr

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78215

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Eric Lawitz

More Information

Sponsor

GlaxoSmithKline

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Keywords

Cirrhosis
Efimosfermin
Fibrosis
Metabolic dysfunction-associated
Steatohepatitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.