Phase II Study of THDBH120 Injection in Overweight or Obese Subjects

Официальное название

A Multicenter, Randomized, Double-blind, Placebo-Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of THDBH120 Injection in Overweight or Obese Subjects

Обзор

To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment.

Вмешательства

• Препарат THDBH120 injection
  Participants received THDBH120 by subcutaneous injection.
• Препарат Placebo of THDBH120 injection
  Participants received placebo by subcutaneous injection.

Первичные конечные точки

• Percentage change in body weight [Срок оценки: Baseline, Week26]

Вторичные конечные точки (10)

• Percentage of Participants Who Achieve ≥5% Body Weight Reduction [Срок оценки: Baseline, Week26]
• Percentage of Participants Who Achieve ≥10% Body Weight Reduction [Срок оценки: Baseline, Week26]
• Percentage of Participants Who Achieve ≥15% Body Weight Reduction [Срок оценки: Baseline, Week26]
• Percentage of Participants Who Achieve ≥20% Body Weight Reduction [Срок оценки: Baseline, Week26]
• Change from baseline in waist circumference after the treatment [Срок оценки: Baseline, Week 26]
• Change from baseline in BMI after the treatment [Срок оценки: Baseline, Week 26]
• Change from baseline in blood pressure after the treatment [Срок оценки: Baseline, Week 26]
• Change from baseline in HbA1c after the treatment [Срок оценки: Baseline, Week 26]
• Change from baseline in total cholesterol after the treatment [Срок оценки: Baseline, Week 26]
• Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) [Срок оценки: Week 30]

Критерии участия

Критерии включения

• Male or female patients 18 to 75 years of age, inclusive;
• Have a BMI ≥ 28 kg/m² or 24 ≤BMI< 28.0 kg/m² with at least 1 weight-related comorbidity at screening: prediabetes, hypertension, metabolic-associated fatty liver disease, dyslipidemia, weight-bearing joint pain, or obstructive sleep apnea syndrome;
• Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.

Критерии исключения

• History of diabetes;
• History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema);
• Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
• A 12-lead electrocardiogram (ECG) shows any of the following at screening: heart rate <50 bpm or >100 bpm; QTcF prolongation (QT interval corrected by Fridericia's formula: QTc = QT/RR\^0.33; >450 ms for males, >470 ms for females); PR interval >200 ms; presence of long QT syndrome; second- or third-degree atrioventricular block; left bundle branch block; complete right bundle branch block; Wolff-Parkinson-White syndrome; or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the clinical trial.

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

• The Second Xiangya Hospital of Central South University — Чанша

Идентификаторы

NCT: NCT07036601 · THDBH120L202

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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