En undersøgelse af LY3502970 i sunde deltagere
15. juni 2026 opdateret af: Eli Lilly and Company
En enkelt- og multiple-stigende dosisundersøgelse for at evaluere sikkerheden, tolerabiliteten, farmakokinetikken og farmakodynamikken af LY3502970 hos raske forsøgspersoner
Hovedformålet med denne undersøgelse er at bestemme:
- Sikkerheden af LY3502970 og eventuelle bivirkninger, der kan være forbundet med det.
- Hvor meget LY3502970 kommer ind i blodbanen, og hvor lang tid det tager kroppen at komme af med det.
Denne undersøgelse har 5 dele (A, B, C, D og E). Del A og D involverer en enkelt dosis LY3502970 og vil vare omkring 15 dage. Del B og E involverer flere doser af LY3502970 og vil vare omkring 4 uger. Del C involverer to enkeltdoser af LY3502970 og vil vare omkring 29 dage. Hver deltager vil kun tilmelde sig én del. Screening skal afsluttes inden for 28 dage før studiestart. Denne undersøgelse er kun til forskningsformål og er ikke beregnet til at behandle nogen medicinsk tilstand.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
133
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Texas
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Dallas, Texas, Forenede Stater, 75247
- Covance Dallas
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-
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
14 år til 61 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Beskrivelse
Inklusionskriterier:
- Sunde mænd eller kvinder, som bestemt af medicinsk historie
- Hav sikkerhedslaboratorieresultater inden for normale referenceområder
Ekskluderingskriterier:
- Har kendt allergi over for LY3502970, glukagon-lignende peptid-1 (GLP-1) analoger, relaterede forbindelser
- Unormalt elektrokardiogram (EKG) ved screening
- Betydelig historie med eller aktuelle kardiovaskulære, respiratoriske, lever-, nyre-, gastrointestinale, endokrine, hæmatologiske eller neurologiske lidelser.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Part A 0.3 mg LY3502970
Participants received a single oral dose of 0.3 milligram (mg) LY3502970.
|
Indgives oralt.
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Eksperimentel: Part A 1 mg LY3502970
Participants received a single oral dose of 1 mg LY3502970.
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Indgives oralt.
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Eksperimentel: Part A 3 mg LY3502970
Participants received a single oral dose of 3 mg LY3502970.
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Indgives oralt.
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Eksperimentel: Part A 6 mg LY3502970
Participants received a single oral dose of 6 mg LY3502970.
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Indgives oralt.
|
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Placebo komparator: Part A Placebo
Participants received a single oral dose of Placebo.
|
Indgives oralt.
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Placebo komparator: Part B Placebo
Participants received oral doses of placebo once daily for 4 weeks.
|
Indgives oralt.
|
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Eksperimentel: Part B: 2 mg LY3502970 (Cohort G)
Participants received oral doses of 2 mg LY3502970 once daily for 4 weeks.
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Indgives oralt.
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Eksperimentel: Part B: 2 / 4 / 6 mg LY3502970 (Cohort H)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week followed by 6 mg on the third and fourth week.
|
Indgives oralt.
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Eksperimentel: Part B: 2 / 4 / 8 / 16 mg LY3502970 (Cohort I)
Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 4 mg for second week, 8 mg for third week and 16 mg for fourth week.
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Indgives oralt.
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Eksperimentel: Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort J)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week.
On day 27, midazolam 200 microgram (mcg) was coadministered with 24 mg LY3502970, and 40 mg atorvastatin administered 4 hours after midazolam.
|
Indgives oralt.
Indgives oralt.
Indgives oralt.
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Eksperimentel: Part B: 2 / 5 / 12 / 24 mg LY3502970 (Cohort K)
Participants received oral doses of LY3502970 once daily for 4 weeks, where 2 mg was given on first week, 5 mg on second week, 12 mg on third week and 24 mg on fourth week.
On day 27, 20 mg simvastatin was coadministered with 24 mg LY3502970.
|
Indgives oralt.
Indgives oralt.
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|
Eksperimentel: Part C: 3 mg LY3502970 (Fasted/Fed)
Part C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period 1 (fasted condition), followed by administration in treatment period 2 (fed condition), with a washout period of at least 5 days between periods. |
Indgives oralt.
|
|
Eksperimentel: Part C: 3 mg LY3502970 (Fed/Fasted)
Part C of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in treatment period1 (fed condition), followed by administration in treatment period 2 (fasted condition), with a washout period of at least 5 days between periods. |
Indgives oralt.
|
|
Aktiv komparator: Part D: 3 mg LY3502970 Prototype Formulation
Part D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of 3 mg LY3502970 in a controlled-release prototype formulation. |
Indgives oralt.
|
|
Placebo komparator: Part D: Placebo Prototype Formulation
Part D of the study is exploratory, conducted to study exploratory objectives. Participants received a single oral dose of placebo in a controlled-release prototype formulation. |
Indgives oralt.
|
|
Eksperimentel: Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 1)
Part E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 1 for the fourth week. |
Indgives oralt.
|
|
Eksperimentel: Part E: 2 / 5 / 12 / 24 mg LY3502970 (24 mg as Formulation 2)
Part E of the study is exploratory, conducted to study exploratory objectives. Participants received oral doses of LY3502970 once daily for 4 weeks where 2 mg was given for first week, 5 mg for second week, 12 mg for third week and 24 mg as formulation 2 for the fourth week. |
Indgives oralt.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parts A and B: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Tidsramme: Baseline through Follow-up (up to Day 42)
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An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience (that is, immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
The number of participants with one or more SAEs considered by the investigator to be related to study drug administration is reported.
An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
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Baseline through Follow-up (up to Day 42)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
Tidsramme: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
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PK: Cmax of LY3502970
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Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
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Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970
Tidsramme: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
|
PK: AUC(0-tlast) of LY3502970
|
Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
|
|
Part A: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970
Tidsramme: Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
|
PK: Tmax of LY3502970
|
Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96 hours post-dose
|
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Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1
Tidsramme: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
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PK: Cmax of LY3502970
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Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
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Part B: PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 28
Tidsramme: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
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PK: Cmax of LY3502970
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Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
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Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1
Tidsramme: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
|
PK: AUC(0-tlast) of LY3502970
|
Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
|
|
Part B: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 28
Tidsramme: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
|
PK: AUC(0-tlast) of LY3502970
|
Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
|
|
Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 1
Tidsramme: Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
|
PK: Tmax of LY3502970
|
Day 1 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24 hours post-dose)
|
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Part B: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970 on Day 28
Tidsramme: Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
|
PK: Tmax of LY3502970
|
Day 28 (pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 96, 168, 336 hours post-dose)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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)
12. juni 2019
Primær færdiggørelse (Faktiske)
2. november 2020
Studieafslutning (Faktiske)
2. november 2020
Datoer for studieregistrering
Først indsendt
25. april 2019
Først indsendt, der opfyldte QC-kriterier
25. april 2019
Først opslået (Faktiske)
29. april 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Organiske kemikalier
- Heterocykliske forbindelser, 1-ring
- Heterocykliske forbindelser
- Heterocykliske forbindelser, 2-ring
- Heterocykliske forbindelser, smeltet ring
- Fedtsyrer
- Lipider
- Azoler
- Kulbrinter
- Kulbrinter, cyklisk
- Naphthalenes
- Polycykliske aromatiske kulbrinter
- Kulbrinter, aromatisk
- Polycykliske forbindelser
- Benzazepiner
- Pyrroles
- Heptanesyrer
- Benzodiazepiner
- Lovastatin
- Atorvastatin
- Midazolam
- Simvastatin
- ellerForGlipron
Andre undersøgelses-id-numre
- 17416
- J2A-MC-GZGA (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
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .