NCT07036601招募中2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 276
- 试验地点
- 1
- 主要终点
- Percentage change in body weight
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
THDBH120 injection
Experimental
干预措施: THDBH120 injection (Drug)
Placebo of THDBH120 injection
Placebo Comparator
干预措施: Placebo of THDBH120 injection (Drug)
结局指标
主要结局
Percentage change in body weight
时间窗: Baseline, Week26
次要结局
- Percentage of Participants Who Achieve ≥5% Body Weight Reduction(Baseline, Week26)
- Percentage of Participants Who Achieve ≥10% Body Weight Reduction(Baseline, Week26)
- Percentage of Participants Who Achieve ≥15% Body Weight Reduction(Baseline, Week26)
- Percentage of Participants Who Achieve ≥20% Body Weight Reduction(Baseline, Week26)
- Change from baseline in waist circumference after the treatment(Baseline, Week 26)
- Change from baseline in BMI after the treatment(Baseline, Week 26)
- Change from baseline in blood pressure after the treatment(Baseline, Week 26)
- Change from baseline in HbA1c after the treatment(Baseline, Week 26)
- Change from baseline in total cholesterol after the treatment(Baseline, Week 26)
- Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)(Week 30)
研究者
研究点 (1)
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