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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)

11 november 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

274

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

  • Argentina
      • Buenos Aires, Argentina, 1061
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Raul Adrover
      • CABA, Argentina, C1056ABI
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Maria Anders
      • Ciudad AutOnoma de Buenos Aire, Argentina, 1118
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Nora Cejas
      • Rosario, Argentina, S2002
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Juan Favareto
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Maria Daniela Pérez
  • Förenta staterna
    • Arizona
      • Chandler, Arizona, Förenta staterna, 85224-4711
        • Rekrytering
        • GSK Investigational Site
        • Huvudutredare:
          • Anita Kohli
        • Kontakt:
        • Kontakt:
    • Florida
      • Miami Lakes, Florida, Förenta staterna, 33016
        • Rekrytering
        • GSK Investigational Site
        • Huvudutredare:
          • William Sanchez
        • Kontakt:
        • Kontakt:
    • Kansas
      • Topeka, Kansas, Förenta staterna, 66606
        • Rekrytering
        • GSK Investigational Site
        • Huvudutredare:
          • Shekhar Challa
        • Kontakt:
        • Kontakt:
    • Texas
      • Fort Worth, Texas, Förenta staterna, 76104
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Thomas Cotter
      • San Antonio, Texas, Förenta staterna, 78215
        • Rekrytering
        • GSK Investigational Site
        • Huvudutredare:
          • Eric Lawitz
        • Kontakt:
        • Kontakt:
  • Kanada
    • Ontario
      • Toronto, Ontario, Kanada, M1S 4T7
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Anshul Arora
  • Sydkorea
      • Pusan, Sydkorea, 49241
        • Rekrytering
        • GSK Investigational Site
        • Huvudutredare:
          • Jeong Heo
        • Kontakt:
        • Kontakt:
      • Seoul, Sydkorea, 05505
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Won-Mook Choi
      • Seoul, Sydkorea, 135-710
        • Rekrytering
        • GSK Investigational Site
        • Kontakt:
        • Kontakt:
        • Huvudutredare:
          • Dong Hyun Sinn

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: Placebo

Participants will receive placebo.
Läkemedel: Placebo

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

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

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

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

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

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

Efimosfermin alfa will be administered.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from Baseline in vibration-controlled transient elastography-liver stiffness measurement (VCTE-LSM)
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

GlaxoSmithKline

Utredare

  • Studierektor: GSK Clinical Trials, GlaxoSmithKline

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

31 augusti 2026

Primärt slutförande (Beräknad)

11 augusti 2028

Avslutad studie (Beräknad)

14 januari 2030

Studieregistreringsdatum

Först inskickad

21 augusti 2026

Först inskickad som uppfyllde QC-kriterierna

21 augusti 2026

Första postat (Faktisk)

27 augusti 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

11 november 2026

Senast verifierad

1 november 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 306837
  • 2026-526391-23 (Annan identifierare: EU CT Number)
  • 2026-526391-23 (Registeridentifierare: CTIS (EU))

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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

Tidsram för IPD-delning

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.

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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