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A Study of LY3981314 in Participants With Autoimmune Hepatitis

5. november 2026 opdateret af: Eli Lilly and Company

An Open Label, Single-Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effect of LY3981314 in Patients With Autoimmune Hepatitis

The purpose of the study is to assess if a single dose of LY3981314 is safe in participants with autoimmune hepatitis. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body

The study will last about 30 weeks.

Studieoversigt

Status

Ikke rekrutterer endnu

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

12

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

  • Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  • Telefonnummer: 1-317-615-4559
  • E-mail: LillyTrials@Lilly.com

Undersøgelse Kontakt Backup

Studiesteder

    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Health
        • Ledende efterforsker:
          • Craig Lammert
        • Kontakt:
          • Telefonnummer: 317-278-9292
    • Texas
      • Dallas, Texas, Forenede Stater, 75203
        • Methodist Dallas Medical Center
        • Ledende efterforsker:
          • Parvez Mantry
        • Kontakt:
          • Telefonnummer: 214-947-4450

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Have a confirmed diagnosis of autoimmune hepatitis (AIH) for greater than or equal to (≥) 6 months according to American Association for the Study of Liver Diseases diagnostic criteria (Appendix 8, Section 10.8)

  • Have alanine aminotransferase (ALT) greater than (>) 1.5x upper limit of normal (ULN) to less than (<) 5x ULN

  • Have elevated soluble FAS (sFAS) based on Sponsor predetermined threshold

  • Be on a stable immunosuppressive medication regimen for AIH with no dose changes or weaning of treatment for ≥8 weeks prior to screening, and no anticipated medication adjustments until after the post-treatment liver biopsy at Day 29. The following medications are permitted for the management of AIH:

    • Azathioprine
    • 6-Mercaptopurine
    • Inhibitors of inosine monophosphate dehydrogenase (mycophenolate mofetil, mycophenolate sodium, mycophenolic acid)
    • Tacrolimus
    • Cyclosporine
    • Corticosteroids at a dose equivalent to less than or equal to (≤) 10 mg of prednisone per day

Exclusion Criteria:

  • Have clinical, laboratory, histological, or imaging evidence of cirrhosis

  • Have a controlled attenuation parameter (CAP) score >300 decibel-milliwatt (dB/m) as measured by transient elastography

  • Have clinical evidence of hepatic decompensation as defined by the presence of any of the following abnormalities

    • international normalized ratio >1.3
    • history of esophageal varices, ascites or hepatic encephalopathy
  • Have or had other forms of chronic liver disease per Medical History:

    • alcoholic liver disease
    • hepatitis B
    • hepatitis C
    • history of primary biliary cholangitis or primary sclerosing cholangitis
    • history of celiac disease, or other autoimmune disorders including immune-checkpoint related hepatitis associated with elevated aminotransferases
    • uncontrolled thyroid disease
    • current drug-induced liver disease based on typical exposure and history
    • metabolic dysfunction associated steatohepatitis, Wilson's disease, hemochromatosis, alpha-1-antitrypsin deficiency, or cystic fibrosis-related liver disease
    • suspected or proven liver cancer
    • any other physician confirmed liver disease other than AIH
  • Have any medical condition that, in the opinion of the investigator, may increase the risk of complications related to liver biopsy (for example, a known coagulopathy, inherited disorders of hemostasis, sickle cell disease, amyloidosis)

  • Have any of the following laboratory abnormalities at screening:

    • Platelet count <150,000/cubic millimeter (mm³)

    • Hemoglobin

      • <10 grams per deciliter (g/dL) for individuals assigned female at birth (AFAB)
      • <11 g/dL for individuals assigned male at birth (AMAB)
    • Absolute neutrophil count <1000/mm³

    • Transferrin saturation >50 percentage (%) (except when it has been demonstrated that a diagnosis of hemochromatosis has been excluded by genetic testing or when a previous liver biopsy has demonstrated no evidence of iron overload.)

    • Total bilirubin > ULN unless known Gilbert's syndrome per Medical History.

      • Gilbert's syndrome participant must have normal direct bilirubin; if diagnosis of Gilbert's cannot be confirmed by medical records, participant may not participate in the study
    • Have renal impairment measured as estimated glomerular filtration rate<60 milliliters per minute (mL/min)/1.73 square meter (m²), calculated using the Chronic Kidney Disease Epidemiology Collaboration Creatinine Equation (2021 version), as determined by the local laboratory during screening

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: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: LY3981314

LY3981314 administered subcutaneously (SC)

Administered SC

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Tidsramme: Baseline up to Approximately Week 25
Baseline up to Approximately Week 25

Sekundære resultatmål

Resultatmål
Tidsramme
Pharmacokinetics (PK): Plasma Concentrations of LY3981314
Tidsramme: Baseline Up to Approximately Week 25
Baseline Up to Approximately Week 25

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

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 (Anslået)

1. december 2026

Primær færdiggørelse (Anslået)

1. juni 2028

Studieafslutning (Anslået)

1. juni 2028

Datoer for studieregistrering

Først indsendt

5. november 2026

Først indsendt, der opfyldte QC-kriterier

5. november 2026

Først opslået (Faktiske)

10. november 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. november 2026

Sidst verificeret

1. november 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 27811
  • J6H-MC-KXAB (Anden identifikator: Eli Lilly and Company)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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