- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06945406
En studie av LY4057996 hos friske deltakere og deltakere med diabetes type 1 og type 2 (YKAA)
En fase 1 -studie for å vurdere sikkerhet, toleranse, farmakokinetikk og farmakodynamikk av LY4057996 hos friske deltakere og deltakere med type 1 og type 2 diabetes
The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
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
-
-
-
Neuss, Tyskland, 41460
- Rekruttering
- Profil Institut für Stoffwechselforschung
-
Hovedetterforsker:
- Oliver Klein
-
Ta kontakt med:
- Telefonnummer: +49 (0) 2131 4018 180
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Part A for Healthy Participants:
- Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment
Part A for Type 2 Diabetes (T2DM) Participants:
- Are participants with T2DM diagnosed greater than 1 year before enrollment,
- On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)
- Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening
Part B
- Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
- HbA1c 6% to 8.5% inclusive at screening
Part C
- Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
- HbA1c 6 to 8.5% inclusive at screening
All Parts
- Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)
- No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants
Exclusion Criteria:
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
- Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening
All Parts
- Cardiovascular: no significant history of cardiovascular disease (CVD)
- Gastrointestinal: have gastroparesis or have undergone gastric surgery
- Hepatic: have acute or chronic hepatitis
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: LY4057996 Part A (Cohorts A1-A5)
LY4057996 administered subcutaneously (SC) and/or intravenously (IV) |
Administered SC Administered IV |
|
Placebo komparator: Placebo Part A (Cohort A1-A5)
Placebo administered SC and/or IV |
Administered SC Administered IV |
|
Eksperimentell: LY4057996 Part B
LY4057996 administered SC |
Administered SC |
|
Eksperimentell: LY4057996 Part C
LY4057996 and interventions of pre-study basal insulin and Lispro administered SC |
Administered SC Administered SC Administered SC |
|
Aktiv komparator: Degludec Part A (Cohort A2-A5)
Degludec administered SC and/or IV |
Administered SC Administered IV |
|
Aktiv komparator: Degludec Part B
Degludec administered SC |
Administered SC |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
Tidsramme: Baseline to Study Completion (Up to 47 Weeks)
|
A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module |
Baseline to Study Completion (Up to 47 Weeks)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996
Tidsramme: Baseline to Study Completion (Up to 47 Weeks)
|
PK: AUC of LY4057996 |
Baseline to Study Completion (Up to 47 Weeks)
|
|
PK: Maximum Concentration (Cmax) of LY4057996
Tidsramme: Baseline to Study Completion (Up to 47 Weeks)
|
PK: Cmax of LY4057996 |
Baseline to Study Completion (Up to 47 Weeks)
|
|
Pharmacodynamic (PD): Change from Baseline in Fasting Glucose
Tidsramme: Baseline to Study Completion (Up to 47 Weeks)
|
PD: Change from Baseline in Fasting Glucose |
Baseline to Study Completion (Up to 47 Weeks)
|
|
PD: AUC of Glucose Infusion Rate (GIR)
Tidsramme: Baseline Up to 10 weeks
|
PD: AUC of GIR |
Baseline Up to 10 weeks
|
Samarbeidspartnere og etterforskere
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
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 27329
- 2024-519151-28-00 (Ctis)
- J6B-MC-YKAA (Annen identifikator: Eli Lilly and Company)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
produkt produsert i og eksportert fra USA
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. .