A Study of LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS).
12. november 2026 oppdatert av: Eli Lilly and Company
A Phase 1b, Randomized, Placebo-Controlled, Participant and Investigator-Blinded, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Cytochrome P450 Interaction of Orally Administered LY3873862 in Participants With Sporadic or Familial Amyotrophic Lateral Sclerosis
The main purpose of this study in participants with Sporadic or Familial Amyotrophic Lateral Sclerosis (ALS) is to test the safety of different doses and to determine the amount of LY3873862 that gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last up to approximately 13 weeks and will include 6 clinic visits.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
32
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-post: LillyTrials@Lilly.com
Studer Kontakt Backup
- Navn: Physicians interested in becoming principal investigators please contact
- E-post: clinical_inquiry_hub@lilly.com
Studiesteder
-
-
-
Montreal, Canada, H3A 2B4
- Montreal Neurological Institute and Hospital
-
Hovedetterforsker:
- Angela Genge
-
Ta kontakt med:
- Telefonnummer: 514-449-8741
-
Toronto, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
Hovedetterforsker:
- Agessandro Abrahao
-
Ta kontakt med:
- Telefonnummer: (416) 480-6100 x687561
-
-
-
-
California
-
San Francisco, California, Forente stater, 94109
- Sutter Health Research Institute- California Pacific Medical Center, Van Ness Campus
-
Hovedetterforsker:
- Jonathan Katz
-
Ta kontakt med:
- Telefonnummer: (415) 600-3604
-
-
Colorado
-
Aurora, Colorado, Forente stater, 80045
- University of Colorado Anschutz
-
Hovedetterforsker:
- Laura Foster
-
-
District of Columbia
-
Washington D.C., District of Columbia, Forente stater, 20007
- Georgetown University Medical Center
-
Hovedetterforsker:
- Shakti Nayar
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60611
- Northwestern University
-
Hovedetterforsker:
- Senda Ajroud-Driss
-
Ta kontakt med:
- Telefonnummer: 312-503-0671
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02114
- Healey and AMG Center for ALS at Mass General Hospital
-
Hovedetterforsker:
- Doreen Ho
-
Ta kontakt med:
- Telefonnummer: 617-724-3914
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Have a diagnosis of sporadic or familial Amyotrophic Lateral Sclerosis (ALS) (definite, probable, laboratory probable) made by physician experienced with management of ALS as defined by the World Federation of Neurology revised El Escorial criteria.
- Have an ALS symptom onset as determined by the investigator within 24 months of screening.
- Have a body mass index within the range 18 to 35 kilograms per square meter (kg/m²) (inclusive).
- Are individuals assigned male at birth (AMAB) or assigned female at birth (AFAB), including both individuals of childbearing potential (IOCBP) and individuals not of childbearing potential (INOCBP). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Are able to safely swallow solids or liquids, or both.
Exclusion Criteria:
- Have a history or presence of medical illness that, in the judgment of the investigator, indicates a medical problem that would preclude study participation including, but not limited to cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, neurologic, convulsions, or any clinically significant laboratory abnormality.
- Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems at screening.
- Have a slow vial capacity (SVC) less than (<) 50% predicted value (for sex, age, ethnic origin, and height) at screening.
- Have significant hepatic abnormalities (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2 times (×) upper limit of normal (ULN) or total bilirubin (TBL) >1.5× ULN, in asymptomatic individuals with a history of Gilbert's syndrome, use TBL of >2× ULN).
- Have a significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per 1.73 square meters (eGFR<60 mL/min/1.73m²)).
- If taking riluzole, must be on a stable dose for more than 30 days (prior to Day 1).
- If taking intravenous or oral edaravone, must have completed 2 treatment cycles (prior to Day 1).
- Are currently taking or plan to take tofersen for the duration of the study.
- Show evidence of Human Immunodeficiency Virus (HIV) and/or positive human HIV antibodies.
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
- Have a positive Hepatitis C Virus (HCV) antibody test. Participants with a positive HCV antibody test at screening can be included only if a confirmatory HCV Ribonucleic Acid (RNA) test is negative.
- Have an abnormal blood pressure judged to be clinically significant by the investigator.
- Have a history of clinically significant back pain, pathological conditions of the back, or back injury (for example, degenerative disease, spinal deformity, or spinal surgery), have a local infection at the intended site of the lumbar puncture (LP) that may predispose to complications or technical difficulty with LP.
- Are taking or intend to take inhibitors or inducers of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A4 from 14 days prior to the first dose of any study intervention, or for 5 half lives (whichever is longer), until the final PK sample is collected.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: LY3873862 or Placebo (Cohort 1)
LY3873862 or placebo administered orally |
Administered orally Administered orally |
|
Eksperimentell: LY3873862 or Placebo (Cohort 2)
LY3873862 or placebo administered orally with a CYP450 drug cocktail |
Administered orally Administered orally CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally. |
|
Eksperimentell: LY3873862 or Placebo (Cohort 3)
LY3873862 or placebo administered orally with a CYP450 drug cocktail |
Administered orally Administered orally CYP450 Drug Cocktail (caffeine, midazolam, flurbiprofen, dextromethorphan and omeprazole) administered orally. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Number of Patients with One or More Treatment Emergent Adverse Events Considered by the Investigator to be Related to Study Drug Administration
Tidsramme: Baseline, Day 28
|
Baseline, Day 28
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY3873862
Tidsramme: Baseline, Day 7
|
Baseline, Day 7
|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3873862
Tidsramme: Baseline, Day 7
|
Baseline, Day 7
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- 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
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. november 2026
Primær fullføring (Antatt)
1. november 2027
Studiet fullført (Antatt)
1. november 2027
Datoer for studieregistrering
Først innsendt
14. oktober 2026
Først innsendt som oppfylte QC-kriteriene
14. oktober 2026
Først lagt ut (Faktiske)
20. oktober 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. november 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
12. november 2026
Sist bekreftet
1. november 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 27886
- J3X-MC-LYGD (Annen identifikator: Eli Lilly and Company)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .