NCT07020884已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetic Characteristics of ZT002 Injection in Subjects With Overweight or Obesity
Beijing QL Biopharmaceutical Co.,Ltd16 个研究点 分布在 1 个国家目标入组 303 人开始时间: 2024年8月14日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 303
- 试验地点
- 16
- 主要终点
- The percentage change from baseline in weight after 24 weeks of treatment.
研究概览
简要总结
This study will evaluate the percentage change from baseline in weight after 24 weeks of treatment with ZT002 Injection in subjects with overweight/obesity.
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
- •Age ≥ 18 years and ≤ 75 years.
- •BMI ≥28 kg/m², or 24 kg/m2 ≤ BMI < 28 kg/m2 with at least one comorbidity (pre-diabetes, hypertension, hyperlipidemia, fatty liver, obstructive sleep apnoea syndrome due to overweight, weight-bearing joint pain, etc.)
- •Weight change is not more than 5% with diet and exercise control alone within 3 months prior to screening.
排除标准
- •Previous diagnosis of diabetes; or HbA1c ≥
- •5% or fasting blood glucose ≥ 7.0 mmol/L at screening.
- •Have used medicines or treatments that affect weight within 3 months prior to screening.
- •History of acute or chronic pancreatitis.
- •Personal or family (parents, children, and siblings) history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia type II (MEN2).
- •History of definite mental disease within 2 years prior to screening or prior suicidal tendency or suicidal behavir; or PHQ-9 scale score is ≥ 15 at screening; or C-SSRS questionnaire is either class 4 or 5 at screening.
研究组 & 干预措施
ZT002 Injection dose 1
Experimental
Dose 1 administered subcutaneously (SC), Q2W
干预措施: ZT002 Injection (Drug)
ZT002 Injection dose 2
Experimental
Dose 2 administered subcutaneously (SC),Q2W
干预措施: ZT002 Injection (Drug)
ZT002 Injection dose 3
Experimental
Dose 3 administered subcutaneously (SC),Q4W
干预措施: ZT002 Injection (Drug)
ZT002 Injection dose 4
Experimental
Dose 4 administered subcutaneously (SC), Q4W
干预措施: ZT002 Injection (Drug)
ZT002 Placebo
Placebo Comparator
administered subcutaneously (SC), Q2W or Q4W
干预措施: ZT002 Placebo (Drug)
结局指标
主要结局
The percentage change from baseline in weight after 24 weeks of treatment.
时间窗: baseline, 24 weeks
次要结局
- The proportion of subjects with weight loss of ≥ 5%, ≥ 10%, and ≥ 15% from baseline after 24 weeks of treatment;(24 weeks)
研究者
研究点 (16)
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