An Exploratory Study of Single-Dose and Multiple-Doses IBI3042 in Healthy, Overweight, or Obese Participants
31 de agosto de 2026 actualizado por: Hongwei Jiang
An Exploratory Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-Dose IBI3042 in Healthy or Overweight Participants and Multiple-Dose IBI3042 in Overweight or Obese Participants
The goal of this study is to learn about the safety and tolerability of IBI3042, an investigational oral drug that activates the glucagon-like peptide-1 (GLP-1) receptor. The study will also assess how IBI3042 moves through the body and explore its effects on body weight and related measures. Researchers will evaluate whether single and multiple oral doses of IBI3042 can be administered with acceptable safety and tolerability.
The study has two parts. In Part A, healthy or overweight participants will receive a single oral dose of IBI3042 or placebo. In Part B, overweight or obese participants will receive multiple oral doses of IBI3042 or placebo over 29 days. Participants will be assigned to different dose groups, and dose escalation will be guided by safety, tolerability, and available drug concentration data from earlier groups.
Participants will undergo safety assessments and blood sampling during the study. These assessments will include medical examinations, vital signs, laboratory tests, and electrocardiograms. In Part B, researchers will also assess changes in body weight, body mass index, waist circumference, and other metabolic measures.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
94
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Hongwei Jiang
- Número de teléfono: +86-0379-64830815
- Correo electrónico: jianghw@haust.edu.cn
Ubicaciones de estudio
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Hennan
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Luoyang, Hennan, Porcelana
- The First Affiliated Hospital of Henan University of Science and Technology
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Contacto:
- Caie Wang
- Número de teléfono: +86-0379-64830815
- Correo electrónico: 245454618@qq.com
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Aged 18 to 55 years, inclusive.
- For Part A: BMI ≥20 and<28 kg/m^2 and body weight ≥50 kg.
- For Part B: BMI ≥24 and ≤40 kg/m^2, with stable body weight during the 3 months prior to screening.
- Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective contraception during the study and for 90 days after the last dose.
- Able and willing to comply with study procedures and voluntarily provide written informed consent.
Exclusion Criteria:
- Known or suspected hypersensitivity to any component of the study drug or to GLP-1 receptor agonists.
- History of diabetes or abnormal glycemic parameters at screening.
- Personal or family history of thyroid C-cell carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN 2A or 2B), or calcitonin ≥20 ng/L at screening.
- History of acute or chronic pancreatitis, or clinically significant pancreatic enzyme elevation at screening.
- Use of medications that may significantly affect gastrointestinal motility, appetite, or drug absorption within 3 months prior to screening.
- Clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease that may increase study-related risk or interfere with study assessments.
- Clinically significant abnormalities in physical examination or laboratory tests at screening.
- History of malignancy within 5 years, except for basal cell or squamous cell skin cancer.
- Use of prescription or over-the-counter medications, dietary supplements, or herbal medicines within 2 weeks or 5 half-lives prior to screening, except as permitted by the protocol.
- Participation in another drug or medical device clinical study within 3 months prior to screening or within 5 half-lives of the investigational drug, as applicable.
- Any other condition that, in the investigator's opinion, makes the participant unsuitable for participation in the study.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: IBI3042 treatment Group
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IBI3042 is an investigational oral drug administered as single or multiple doses according to the study protocol.
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Experimental: Placebo Control Group
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Matching oral placebo is administered as single or multiple doses according to the study protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of Participants With Adverse Events (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Abnormal Physical Examination Findings (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Clinically Significant Abnormal Vital Signs (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Number of Participants With Adverse Events (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Number of Participants With Abnormal Physical Examination Findings (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Number of Participants With Clinically Significant Abnormal Vital Signs (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
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Number of Participants With Clinically Significant Abnormal Laboratory Tests (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Number of Participants With Clinically Significant Abnormal Twelve-Lead Electrocardiogram Readings (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Area under the blood concentration-time curve (AUC) (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Peak Plasma Concentration (Cmax) (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
|
Through study completion, an average of 29 days.
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Time to Reach Peak Plasma Concentration (Tmax) (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Apparent Clearance (CL/F) (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Apparent Volume of Distribution (Vz/F) (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Terminal Half-Life (T1/2) (Part A)
Periodo de tiempo: Through study completion, an average of 29 days.
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Through study completion, an average of 29 days.
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Area Under the Plasma Concentration-Time Curve (AUC) (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Peak Plasma Concentration (Cmax) (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Time to Reach Peak Plasma Concentration (Tmax) (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
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Apparent Clearance (CL/F) (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Apparent Volume of Distribution (Vz/F) (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Terminal Half-Life (T1/2) (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Changes in body weight from baseline (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Percentage change in body weight from baseline (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Percentage change in waist circumference from baseline (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Percentage change in body mass index (BMI) from baseline (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
|
Through study completion, an average of 57 days.
|
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Body Mass Index (BMI) change from baseline (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
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Changes in waist circumference from baseline (Part B)
Periodo de tiempo: Through study completion, an average of 57 days.
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Through study completion, an average of 57 days.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
2 de septiembre de 2026
Finalización primaria (Estimado)
20 de marzo de 2027
Finalización del estudio (Estimado)
2 de mayo de 2027
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
31 de agosto de 2026
Publicado por primera vez (Actual)
3 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CIBI3042T001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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