A Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

Официальное название

A Multicenter, Multiple-dose Escalation, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity

Обзор

The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity

Подробное описание

In this study, eligible participants will be randomized to receive either oral ecnoglutide tablet or placebo once daily for up to 3 weeks (Cohort C1) or 4 weeks (Cohort C2), or once weekly for up to 24 weeks (Cohort C3 and C4), including a dose escalation period.

Вмешательства

• Препарат ecnoglutide tablets
  oral tablets
• Препарат placebo with matching dosage
  oral tablets

Первичные конечные точки

• The incidence and severity of adverse events [Срок оценки: up to day 204]

Вторичные конечные точки (10)

• Pharmacokinetics of oral ecnoglutide tablet [Срок оценки: up to day 204]
• Change of body weight from baseline [Срок оценки: up to day 204]
• Change of BMI from baseline [Срок оценки: up to day 204]
• Change of waist circumference from baseline [Срок оценки: up to day 204]
• Change of hip circumference from baseline [Срок оценки: up to day 204]
• Change of neck circumference from baseline [Срок оценки: up to day 204]
• Change of waist/hip ratio from baseline [Срок оценки: up to day 204]
• Change of fasting blood glucose from baseline [Срок оценки: up to day 204]
• Change of fasting insulin from baseline [Срок оценки: up to day 204]
• Change of lipid profile from baseline [Срок оценки: up to day 204]

Критерии участия

Критерии включения

• At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight >60.0 kg for male, and weight >50.0 kg for female;
• Self-declaration of body weight change <5% within 3 months prior to informed consent ;

Критерии исключения

• 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 TI-RADS≥ class 3), thyroid cancer, 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 acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.
• Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• China-Japan Friendship Hospital — Пекин

Идентификаторы

NCT: NCT07243171 · SCW0503-1012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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