- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06148272
Un estudio de LY3971297 en participantes sanos y participantes con obesidad e hipertensión
Un estudio de dosis única ascendente y de dosis múltiples ascendentes de LY3971297 en participantes sanos y participantes con obesidad e hipertensión
The purpose of this study is to measure side effects of LY3971297 injection administered under the skin in healthy participants and obese participants with high blood pressure (BP). Blood tests will be performed to check how much LY3971297 gets into the bloodstream and how long it takes the body to eliminate it. This is a 7-part study. The study duration will be approximately 60 days for Parts A and F, and approximately 90 days for Parts B, C, D, E, and G.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Anaheim, California, Estados Unidos, 92801
- CenExel ACT
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Florida
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Miami, Florida, Estados Unidos, 33172
- Clinical Pharmacology of Miami
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Texas
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San Antonio, Texas, Estados Unidos, 78209
- ICON Early Phase Services
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Fukuoka, Japón, 812-0025
- Hakata Clinic
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Hachiōji, Japón, 192-0071
- P-One Clinic
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Shinjuku-ku, Japón, 160-0004
- Clinical Research Hospital Tokyo
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Singapore, Singapur, 138623
- Lilly Centre for Clinical Pharmacology
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- For Parts A, B, C, E, and F: Overtly healthy males or females as determined by medical history and physical examination
- For Parts A, B, C, E, and F: Have a screening body mass index (BMI) in the range of 18.5 to 35 kilogram per square meter (kg/m²), inclusive, with no significant weight gain or loss in the past 3 months prior to screening
- For Part C, to qualify as Chinese for the purpose of this study, all the participants' biological grandparents must be of exclusive Chinese descent and born in China
- For Part D, participants must have a stable dose of medications within the past 3 months prior to screening
- For Part D, obesity BMI in the range of 30 to 40 kg/m², inclusive, with a waist circumference of at least 102 centimeter (cm) for men and at least 89 cm for women for participants of US sites only. For participants of Singaporean, South Asian, Japanese, and/or Chinese Origin at sites outside the US, the BMI range is 27 to 40 kg/m2 and the waist circumference is at least 90 cm for men and at least 80 cm for women
- For Part E, to qualify as a participant of the first-generation Japanese origin, the participant, the participant's biological parents, and all of the participants' biological grandparents must be of exclusive Japanese descent and born in Japan
- Male participants must agree to adhere to contraception restrictions and female participants must be women not of childbearing potential
- For Part G, have a screening BMI in the range of 18.5 to 40 kg/m², inclusive, with no significant weight gain or loss in the past 3 months prior to screening
- For Part G, participants have a decreased estimated glomerular filtration rate (eGFR)
- For Parts D and G, participants are allowed to have stable background treatment for hypertension, type 2 diabetes mellitus (on oral drug therapy and/or long-acting insulin), dyslipidemia (on statin therapy) and/or hypothyroidism as determined by the investigator
- For Part G, Participants should be on a stable dose of angiotensin converting enzyme inhibitor or angiotensin II receptor blocker
Exclusion Criteria:
- Have a history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders
- Have known or ongoing psychiatric disorders that, in the opinion of the investigator, increases the risks associated with study participation
- Have blood pressure and/or pulse rate constituting a risk as determined by the investigator
- Have a systolic blood pressure (BP) of less than 100 millimeters of mercury (mmHg)
- Diagnosed with orthostatic hypotension defined as a decrease in systolic blood pressure of equal to or greater than 20 mmHg or a decrease in diastolic blood pressure of equal to or greater than 10 mmHg when compared with BP from the supine position
- For US sites: have donated blood of more than 500 mL within the previous 3 months of screening or intend to donate blood during the course of the study
- For Singapore sites: Have donated blood of more than 450 mL or more in the past 3 months or provided any blood donation within the past 1 month before screening
- Consume more than 10 cigarettes per day (or the equivalent) or are unable or unwilling to abstain from nicotine
- Have alcohol intake that exceeds recommended alcohol consumption limits per local regulation or are unwilling to stop alcohol consumption 24 hours prior to dosing until discharge
- For Part D, has concurrent use or anticipated use of phosphodiesterase 5 inhibitor such as vardenafil, tadalafil, and sildenafil, soluble guanylyl cyclase activators (such as riociguat and vericiguat)
- For Parts D and G, has concurrent or anticipated use of long-acting nitrates or nitric oxide (NO) donors
- For Part D, has current use of more than 3 mechanism of actions for treatment of hypertension
- For Part G, has previous or current diagnosis of primary glomerulopathy, vasculitic renal disease, prior dialysis or unstable rapidly progressing renal disease, autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis, or anti-neutrophil cytoplasm antibody-associated vasculitis
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: LY3971297 (Part A)
Single ascending doses of LY3971297 administered subcutaneously (SC) in healthy participants |
Administered SC |
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Experimental: LY3971297 (Part B)
Multiple ascending doses of LY3971297 administered SC in healthy participants |
Administered SC |
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Experimental: LY3971297 (Part C)
Multiple ascending doses of LY3971297 administered SC in healthy Chinese participants |
Administered SC |
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Experimental: LY3971297 (Part D)
Multiple ascending doses of LY3971297 administered SC |
Administered SC |
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Experimental: LY3971297 (Part E)
Multiple doses of LY3971297 administered SC in healthy Japanese participants |
Administered SC |
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Comparador de placebos: Placebo (Part A, B, C, D, E, & G)
Placebo administered SC |
Administered SC |
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Experimental: LY3971297 (Part F)
Single doses of LY3971297 administered intravenously (IV) in healthy participants |
Administered IV |
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Experimental: LY3971297 (Part G)
Multiple doses of LY3971297 administered SC |
Administered SC |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Part A and F: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Periodo de tiempo: Baseline (Day of Exposure) to Day 29 post-dose
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Part A and F: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module |
Baseline (Day of Exposure) to Day 29 post-dose
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Part B, C, D, E, & G: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Periodo de tiempo: Baseline (Day of Exposure) to Day 57 post-dose
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Part B, C, D, E, & G: A summary of TEAEs and SAEs, regardless of causality, will be reported in the Reported Adverse Events module |
Baseline (Day of Exposure) to Day 57 post-dose
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Part F: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Periodo de tiempo: Baseline Up to Day 29 post-dose for Part F
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Part F: PK: AUC of LY3971297 |
Baseline Up to Day 29 post-dose for Part F
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Part F: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Periodo de tiempo: Baseline Up to Day 29 post-dose for Part F
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Part F: PK: Cmax of LY3971297 |
Baseline Up to Day 29 post-dose for Part F
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Part B, C, D, E, and G: Pharmacokinetics (PK): Area Under the Concentration curve (AUC) of LY3971297
Periodo de tiempo: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
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Part B, C, D, E, and G: PK: AUC of LY3971297 |
Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
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Part B, C, D, E, and G: PK: Maximum Observed Drug Concentration (Cmax) of LY3971297
Periodo de tiempo: Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
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Part B, C, D, E, and G: PK: Cmax of LY3971297 |
Predose on day 1 up to 29 days post-dose for Part A and pre-dose on day 1 up to 57 days post-dose for Part B, C, D, E, and G
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 18771
- J4O-MC-EZHA (Otro identificador: Eli Lilly and Company)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .