- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07929298
A Study to Evaluate the Safety and Efficacy of Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Safety and Efficacy of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
The aim of the study is to evaluate the safety and efficacy of oral ecnoglutide tablets in Chinese participants with overweight or obesity
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
In this study, eligible participants will be randomized to one of the four cohorts to receive either oral ecnoglutide tablet or placebo for up to 24 weeks, including a dose escalation period.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yao Li
- Número de teléfono: 010-67889253
- Correo electrónico: ra@sciwindbio.com
Ubicaciones de estudio
-
-
Henan
-
Luoyang, Henan, Porcelana
- The First Affiliated Hospital of Henan University of Science & Technology
-
Contacto:
- Hongwei Jiang
- Número de teléfono: 010-67889253
- Correo electrónico: ra@sciwindbio.com
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- At the time of informed consent, BMI≥28.0 kg/m^2 regardless of comorbidities, or 24.0kg/m^2≤BMI<28.0 kg/m^2 with at least one of the comorbidities (prediabetes, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, weight-bearing joint pain, etc.);
- Self-declaration of body weight change <5% within 3 months prior to informed consent;
Exclusion Criteria:
- Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
- Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows C-TIRADS≥ class 4A), Medullary thyroid carcinoma, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
- Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, unstable angina, transient ischemic attack, acute stroke, acute coronary syndrome, congestive heart failure classified as New York Heart Association class III or IV, clinically significant arrhythmias requiring treatment, and cerebrovascular accidents, etc.
- Diagnosis of gastrointestinal diseases with clinical significance within 6 months prior to screening, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
- History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
- HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
- Clinical laboratory test results with clinical significance
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: oral ecnoglutide dose 1
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
Experimental: oral ecnoglutide dose 2
once daily from week1 to week 8, then once weekly from week 9 to week 24 |
oral tablet |
|
Experimental: oral ecnoglutide dose 3
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
|
Comparador de placebos: Placebo
once daily from week1 to week 8 or week 12, then once weekly from week 9 or week 13 to week 24 |
oral tablet |
|
Experimental: oral ecnoglutide dose 4
once daily from week1 to week 12, then once weekly from week 13 to week 24 |
oral tablet |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Percentage Change in Body Weight
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants with ≥5% of Body Weight Loss
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥10% of Body Weight Loss
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Percentage of Participants with ≥15% of Body Weight Loss
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Absolute Change in Body Weight
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in Body Mass Index (BMI)
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood pressure
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in other body measurements
Periodo de tiempo: Baseline, week 24
|
Body measurements include neck circumference, waist circumference, hip circumference |
Baseline, week 24
|
|
Change in lipid profile
Periodo de tiempo: Baseline, week 24
|
Include triglicerides, LDL-C, HDL-C, total cholesterol |
Baseline, week 24
|
|
Change in fasting blood glucose (FBG)
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in HbA1c
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in fasting insulin
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in blood uric acid
Periodo de tiempo: Baseline, week 24
|
Baseline, week 24
|
|
|
Change in liver enzymes
Periodo de tiempo: Baseline, week 24
|
include ALT and AST |
Baseline, week 24
|
|
Adverse events
Periodo de tiempo: Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
|
|
Plasma Concentration of Ecnoglutide
Periodo de tiempo: Week 1 to week 28 (EOS)
|
Week 1 to week 28 (EOS)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Hongwei Jiang, The First Affiliated Hospital of Henan University of Science and Technology
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SCW0503-1121
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.
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