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

29. september 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

274

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Argentina
      • CABA, Argentina, C1056ABI
        • Rekruttering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Maria Anders
  • Forenede Stater
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Rekruttering
        • GSK Investigational Site
        • Ledende efterforsker:
          • Shekhar Challa
        • Kontakt:
        • Kontakt:
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Rekruttering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Thomas Cotter
      • San Antonio, Texas, Forenede Stater, 78215
        • Rekruttering
        • GSK Investigational Site
        • Ledende efterforsker:
          • Eric Lawitz
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo

Participants will receive placebo.
Medicin: Placebo

Placebo will be administered.
Eksperimentel: Efimosfermin alfa Dose Level 1

Participants will receive efimosfermin alfa dose level 1.
Medicin: Efimosfermin alfa

Efimosfermin alfa will be administered.
Eksperimentel: Efimosfermin alfa Dose Level 2

Participants will receive efimosfermin alfa dose level 2.
Medicin: Efimosfermin alfa

Efimosfermin alfa will be administered.
Eksperimentel: Efimosfermin alfa Dose Level 3

Participants will receive efimosfermin alfa dose level 3.
Medicin: Efimosfermin alfa

Efimosfermin alfa will be administered.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from Baseline in a blood test that helps predict the risk of disease progression in liver disease
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to Week 4
Up to Week 4
Number of Participants with Anti-drug antibodies (ADA) against efimosfermin alfa
Tidsramme: Up to Week 56
Up to Week 56
Number of participants with treatment-emergent adverse events (TEAEs) and TEAEs by severity
Tidsramme: Up to Week 60
Up to Week 60
Number of participants with TEAEs leading to discontinuation and TEAEs leading to discontinuation by severity
Tidsramme: Up to Week 60
Up to Week 60
Number of participants with Grade 3 and Grade 4 laboratory abnormalities
Tidsramme: Up to Week 60
Up to Week 60
Number of participants with clinically significant changes in Vital signs
Tidsramme: Up to Week 60
Up to Week 60
Number of participants with clinically significant changes in 12-lead electrocardiogram (ECG) findings
Tidsramme: Up to Week 60
Up to Week 60
Change from Baseline in serum aspartate aminotransferase (AST) (International units per liter)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Efterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

31. august 2026

Primær færdiggørelse (Anslået)

11. august 2028

Studieafslutning (Anslået)

14. januar 2030

Datoer for studieregistrering

Først indsendt

21. august 2026

Først indsendt, der opfyldte QC-kriterier

21. august 2026

Først opslået (Faktiske)

27. august 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 306837
  • 2026-526391-23 (Anden identifikator: EU CT Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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