NCT06256536已完成1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Obese/Overweight Patients
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Incidence of adverse events and serious adverse events
研究概览
简要总结
The study was a multicenter, randomized, double-blind, placebo-controlled phase Ib/IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in Chinese adult obese/overweight patients. This study is divided into Part A and Part B, which are to be conducted simultaneously.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-65 years (inclusive);
- •Obese subjects: BMI ≥ 28.0 kg/m2; or overweight subjects: 24.0 ≤ BMI < 28.0 kg/m2 with at least one comorbidity;
- •Able to understand the procedures and methods in this study; willing to complete the study in strict accordance with the clinical study protocol and sign the ICF voluntarily.
排除标准
- •Suspicion that the subject may be allergic to any study drug or ingredient or congener from the investigator.
- •Subjects with body weight change > 5.0% for any reason (diet, exercise, etc.) within 12 weeks prior to screening.
- •Heart rate < 50 beats/min or > 100 beats/min on 12-lead ECG at screening.
- •Presence of the following clinically significant 12-lead ECG abnormalities at screening.
- •Alcohol abuse within 6 months prior to screening, or reluctance to stop alcohol abuse throughout the study, or a positive breath alcohol test result at screening.
研究组 & 干预措施
GZR18
Experimental
GZR18 injection s.c.
干预措施: GZR18 (Drug)
Placebo
Placebo Comparator
Placebo injection s.c.
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of adverse events and serious adverse events
时间窗: 38 weeks
Changes in weight from baseline to the end of treatment
时间窗: 35 weeks
次要结局
- trough concentrations following consecutive doses(35 weeks)
- Changes in Body mass index (BMI) from baseline to the end of treatment(35 weeks)
- Changes in Percentage of reduction in weight (%) from baseline to the end of treatment(35 weeks)
- Proportion of subjects with ≥5% reduction in body weight from baseline.(35 weeks)
- Changes in Waist circumference from baseline to the end of treatment(35 weeks)
研究者
研究点 (1)
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