A Study to Investigate the Safety and Efficacy of Efimosfermin Alfa Compared With Placebo in Adult Participants With Alcohol-related Liver Disease (ALD) (ALLSTAR)

September 15, 2026 updated by: GlaxoSmithKline

A Dose-finding, Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of Treatment With Efimosfermin Alfa in Adult Participants With Alcohol-related Liver Disease (ALD)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shekhar Challa
        • Contact:
        • Contact:
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Cotter
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eric Lawitz
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo.
Drug: Placebo
Placebo will be administered.
Experimental: Efimosfermin alfa Dose Level 1
Participants will receive efimosfermin alfa dose level 1.
Drug: Efimosfermin alfa
Efimosfermin alfa will be administered.
Experimental: Efimosfermin alfa Dose Level 2
Participants will receive efimosfermin alfa dose level 2.
Drug: Efimosfermin alfa
Efimosfermin alfa will be administered.
Experimental: Efimosfermin alfa Dose Level 3
Participants will receive efimosfermin alfa dose level 3.
Drug: Efimosfermin alfa
Efimosfermin alfa will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
Time Frame: Baseline (Day 1) and up to Week 60
VCTE-LSM is a non-invasive test that uses vibration-controlled transient elastography to measure the stiffness of the liver in kilopascals (kPa)
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
MELD is a scoring system for assessing the severity of chronic liver disease. MELD scores range between 6 and 40, with 40 being the most severe.
Baseline (Day 1) and up to Week 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)
Time Frame: Baseline (Day 1) and up to Week 60
This is a measurement of the AST enzyme in the blood.
Baseline (Day 1) and up to Week 60
Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease
Time Frame: Baseline (Day 1) and up to Week 52
Baseline (Day 1) and up to Week 52
Trough Concentration at steady state (Ctrough,ss) following administration of efimosfermin alfa
Time Frame: Up to Week 56
Up to Week 56
Area Under the concentration-time Curve from Time 0 (pre-dose) to the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa in the subset of participants with optional intensive pharmacokinetics (PK) sampling
Time Frame: Up to Week 4
Up to Week 4
Maximum observed drug concentration (Cmax) of efimosfermin alfa in the subset of participants with optional intensive PK sampling
Time Frame: Up to Week 4
Up to Week 4
Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa
Time Frame: Up to Week 56
Up to Week 56
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Time Frame: Up to Week 60
Up to Week 60
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Time Frame: Up to Week 60
Up to Week 60
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Time Frame: Up to Week 60
Up to Week 60
Number of participants with clinically significant changes in Vital signs
Time Frame: Up to Week 60
Up to Week 60
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings
Time Frame: Up to Week 60
Up to Week 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2026

Primary Completion (Estimated)

August 11, 2028

Study Completion (Estimated)

January 14, 2030

Study Registration Dates

First Submitted

August 21, 2026

First Submitted That Met QC Criteria

August 21, 2026

First Posted (Actual)

August 27, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 306837
  • 2026-526391-23 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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