A Study of BGM0504 Injection in Participants with Obesity or Overweight

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-parallel Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Injection in Chinese Non-diabetes Participants with Overweight or Obese

Обзор

This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.

Вмешательства

• Препарат 5 mg BGM0504 injection
  5mg BGM0504 injection administered subcutaneously (SC) once a week.
• Препарат 10 mg BGM0504 injection administered subcutaneously (SC) once a week
  10mg BGM0504 injection administered subcutaneously (SC) once a week.
• Препарат 15 mg BGM0504 injection
  15mg BGM0504 injection administered subcutaneously (SC) once a week.
• Препарат BGM0504 placebo
  BGM0504 placebo administered SC once a week.

Первичные конечные точки

• Percent Change from Baseline in Body Weight [Срок оценки: Baseline,Week 36]
• Percentage of Participants Who Achieve≥5% Body Weight Reduction [Срок оценки: Baseline,Week 36]

Вторичные конечные точки (10)

• Percent Change From Baseline in Body Weight [Срок оценки: Baseline, Week 52]
• Change From Baseline in Body Weight [Срок оценки: Baseline, Week36 and 52]
• Percentage of Participants Who Achieve≥5% Body Weight Reduction [Срок оценки: Baseline, Week 36 and 52]
• Percentage of Participants Who Achieve≥10% Body Weight Reduction [Срок оценки: Baseline, Week 36 and 52]
• Percentage of Participants Who Achieve≥15%Body Weight Reduction [Срок оценки: Baseline, Week 36 and 52]
• Percentage of Participants Who Achieve≥20% Body Weight Reduction [Срок оценки: Baseline, Week 36 and 52]
• Change From Baseline in Waist Circumference [Срок оценки: Baseline, Week 36 and 52]
• Change From Baseline in Body Mass Index (BMI) [Срок оценки: Baseline, Week 36 and 52]
• Change From Baseline in Fasting Glucose [Срок оценки: Baseline, Week 36 and 52]
• Change From Baseline in Hemoglobin A1c (HbA1c) [Срок оценки: Baseline, Week 36 and 52]

Критерии участия

Критерии включения

• A male or female aged 18 to 65 years inclusive at screening
• BMI≥28 kg/m², or 24.0≤BMI<28.0 kg/m² and previous diagnosis with at least one of the following comorbidities: i. Prediabetes (impaired fasting blood glucose and/or impaired glucose tolerance), hypertension, nonalcoholic fatty liver disease, or one or more of these; ii. Joint pain with weight bearing; iii. Dyspnea caused by obesity or obstructive sleep apnea syndrome
• Weight change < 5.0% (chief complaint) after diet and exercise control for at least 12 weeks before screening
• Female participants who are not pregnant or lactating. Female participants with childbearing potential and their partners should use highly effective, medically accepted contraception, will not have pregnancy and fertility plan, and refrain from donating ovum until one month after the end of the study

Критерии исключения

• Diabetes mellitus
• Known to be allergic to 3 or more kinds of foods or medications, or allergic to GLP-1 agonist, or have a severe allergic disease (asthma, urticaria, eczematous dermatitis, etc.) at screening
• Has been treated with GLP-1 receptor agonists or similar drugs containing the same target, or drugs used for weight control in the three months prior to screening
• Secondary disease or drug-induced obesity, including : elevated cortisol (e.g. Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to diet drug reduction/discontinuation, etc.;
• History of pancreatitis
• Have the currently uncontrolled thyroid diseases with stable treatment dose and clinically significant abnormal results of thyroid function test occurred at screening
• Previous history of moderate or severe depression, or PHQ-9 score ≥15, or history of other serious mental illness, or Any lifetime history of a suicide attempt

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT06704581 · BGM0504-Ⅲ-WL

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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