Recruiting
Phase 2

Efimosfermin Alfa

Sponsor:

GlaxoSmithKline

Code:

NCT07791043

Conditions

Liver Diseases, Alcoholic

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Efimosfermin alfa

Placebo

Study Details

Brief summary:

This is a dose-ranging study to evaluate safety of efimosfermin alfa and to establish proof-of-concept that efimosfermin alfa therapy provides benefit in participants with ALD.

Conditions

Liver Diseases, Alcoholic

Study ID

NCT07791043

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Jan 14, 2030

Anticipated

Primary completion date

Aug 11, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant must be 18 to 75 years of age inclusive, at the time of Screening.
  • Capable of giving signed informed consent prior to the performance of any study-specific procedures.
  • Able and willing to comply with all study assessments and adhere to the protocol schedule of activities.
  • History of heavy alcohol consumption for greater than 6 months at any time prior to Screening.
  • A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:

  • Is a Participant of non-childbearing potential (PONCBP) OR
  • Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of less than (<)1 percentage (%), 30 days prior to and during the study intervention period and for at least 16 weeks after the last dose of study intervention.

Exclusion Criteria:

  • Other primary causes of liver disease (e.g., viral hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, hemochromatosis, alpha-1-antitryspin deficiency, etc.). Alcohol must be the primary cause of liver disease.
  • Co-infection with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or Human immunodeficiency virus (HIV) as indicated from the central lab
  • History of diabetes mellitus (DM), either:

  • Type 1 DM
  • Type 2 DM with unstable glycemic control or with major complications.
  • History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in situ cervical cancer), treated or untreated, within the 3 years prior to Screening 1, regardless of any evidence of local recurrence or metastasis.
  • Current, or history of known hepatocellular carcinoma (HCC).
  • Any major surgery within 3 months prior to Screening 1 or planned during the study
  • Any surgical or medical condition that might jeopardize the individual's safety or compliance with study procedures in the opinion of the investigator.
  • All organ transplant recipients, except for history of corneal transplants, or current listing or active consideration for liver transplant during the Screening period.
  • Poorly controlled hypertension.
  • Evidence of Wernicke-Korsakoff syndrome or alcohol-related dementia.
  • Prior use of a Fibroblast growth factor 21 (FGF21) analogue, including efimosfermin, within the 6 months prior to Screening 1.
  • Individuals with a history of resmetirom use within 3 months prior to Day 1 are to be excluded.
  • Concomitant use of investigational drugs for Metabolic dysfunction-associated steatohepatitis (MASH) or ALD.
  • Current or planned participation in any clinical trial of investigational therapies or medical devices.
  • Exceeding pre-defined laboratory parameters for Triglycerides, Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), International normalised ratio (INR), Albumin, Urine albumin-creatinine ratio (uACR) or Glycosylated Hemoglobin (HbA1c).
  • History of drug abuse within the 12 months prior to Day 1 or evidence of such abuse as indicated by laboratory assays conducted at Screening.
  • History of hypersensitivity (such as anaphylaxis or hepatotoxicity) to study intervention and/or its excipients, drugs of similar biological class, FGF21 protein analogs, Fc-fusion proteins, or other protein-based therapeutics.
  • Overt hepatic encephalopathy (West Haven grade >=2).

Study Design

Enrollment

274 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Efimosfermin alfa Dose Level 1

Participants will receive efimosfermin alfa dose level 1.

experimental: Efimosfermin alfa Dose Level 2

Participants will receive efimosfermin alfa dose level 2.

experimental: Efimosfermin alfa Dose Level 3

Participants will receive efimosfermin alfa dose level 3.

placebo comparator: Placebo

Participants will receive placebo.

Interventions

Efimosfermin alfa

Efimosfermin alfa will be administered.

Placebo

Placebo will be administered.

Primary outcome measure

  • Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM) [ Time Frame: Baseline (Day 1) and up to Week 60 ]
  • Change from Baseline in model for end-stage liver disease (MELD) score [ Time Frame: Baseline (Day 1) and up to Week 60 ]

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

Topeka, Kansas, United States, 66606

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:

Shekhar Challa

GSK Investigational Site

Recruiting

Fort Worth, Texas, United States, 76104

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:

Thomas Cotter

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

More Information

Sponsor

GlaxoSmithKline

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Keywords

  • Efimosfermin alfa
  • Alcohol-related liver disease
  • Liver stiffness measurement
  • Advanced chronic liver disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-09-17.