Recruiting
Phase 2

Efimosfermin Alfa

Sponsor:

GlaxoSmithKline

Code:

NCT06920043

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

Non-alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Efimosfermin

Placebo

Study Details

Brief summary:

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

Conditions

Metabolic Dysfunction-Associated Steatohepatitis

Non-alcoholic Fatty Liver Disease

Study ID

NCT06920043

Start date

Apr 9, 2025

Status verified date

Jul, 2026

Completion date

Jul 10, 2028

Anticipated

Primary completion date

Jul 10, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to understand and sign a written informed consent form (ICF)
  • Age 18 through 75 years at enrollment
  • History or presence of 2 or more of the 5 components of metabolic syndrome
  • Liver biopsy confirmation of MASH consistent with stage F4 fibrosis
  • Other inclusion criteria may apply.

Exclusion Criteria:

  • Individuals with chronic liver disease from other causes, or any history or evidence of decompensated liver disease
  • History of type 1 diabetes
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × the upper limit of normal (ULN)
  • Other exclusion criteria may apply.

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Efimosfermin (Dose 1)

Participants will receive efimosfermin (Dose 1) once every 4 weeks (Q4W).

experimental: Efimosfermin (Dose 2)

Participants will receive efimosfermin (Dose 2) Q4W.

placebo comparator: Placebo

Participants will receive placebo Q4W.

Interventions

Efimosfermin

Efimosfermin will be administered as a subcutaneous injection.

Placebo

Placebo will be administered as a subcutaneous injection.

Primary outcome measure

  • Number of participants with treatment emergent adverse events (TEAEs) [ Time Frame: From Day 1 to 100 weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

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

Locations

GSK Investigational Site

Recruiting

Chandler, Arizona, United States, 85224

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Anita Kohli

GSK Investigational Site

Recruiting

Mesa, Arizona, United States, 85381

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Ann Moore

GSK Investigational Site

Recruiting

Tucson, Arizona, United States, 85712

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Aimee Bachelier

GSK Investigational Site

Recruiting

Fresno, California, United States, 93720

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Muhammad Sheikh

GSK Investigational Site

Recruiting

Lancaster, California, United States, 93534

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Jatinder Pruthi

GSK Investigational Site

Recruiting

Pasadena, California, United States, 91105

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Edward Mena

GSK Investigational Site

Recruiting

Rialto, California, United States, 92377

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Zeid Kayali

GSK Investigational Site

Recruiting

Santa Maria, California, United States, 93458

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Keval Shah

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33156

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Lazaro M Garcia

GSK Investigational Site

Recruiting

Viera, Florida, United States, 32940

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Rosemary Laird

GSK Investigational Site

Recruiting

Marietta, Georgia, United States, 30060

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Aasim Sheikh

GSK Investigational Site

Recruiting

Baltimore, Maryland, United States, 21202

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Paul Thuluvath

GSK Investigational Site

Recruiting

Kansas City, Missouri, United States, 64131

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Bradley Freilich

GSK Investigational Site

Recruiting

New York, New York, United States, 10029

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Frances Lee

GSK Investigational Site

Recruiting

Fayetteville, North Carolina, United States, 28304

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

John Poulos

GSK Investigational Site

Recruiting

Wilson, North Carolina, United States, 27612

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Mitchell Mahmoud

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78745

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Nomita Kim

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78757

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Rohit Puskoor

GSK Investigational Site

Recruiting

Austin, Texas, United States, 78757

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Carmen Landaverde

GSK Investigational Site

Recruiting

Dallas, Texas, United States, 75203

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Parvez Mantry

GSK Investigational Site

Recruiting

Georgetown, Texas, United States, 78626

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Nirupama Jerome

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77030

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Prasun Jalal

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77030

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Joseph Galati

GSK Investigational Site

Recruiting

Houston, Texas, United States, 77079

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

David Huang

GSK Investigational Site

Recruiting

Pasadena, Texas, United States, 77505

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Rukan Daccak

GSK Investigational Site

Recruiting

Pearland, Texas, United States, 77584

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Jignesh Shah

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78215

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Eric Lawitz

GSK Investigational Site

Recruiting

San Antonio, Texas, United States, 78229

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Daniel Santillano

GSK Investigational Site

Recruiting

Waco, Texas, United States, 76710

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Gregg Lucksinger

GSK Investigational Site

Recruiting

Richmond, Virginia, United States, 23249

Contacts

US GSK Clinical Trials Call Center

877-379-3718GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

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

Principal Investigator:

Michael Fuchs

More Information

Sponsor

GlaxoSmithKline

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Keywords

  • Fibroblast growth factor
  • Stage 4 fibrosis
  • Compensated Cirrhosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-07-08.