NCT06728124进行中（未招募）3 期
A Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Obese/Overweight Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 630
- 试验地点
- 1
- 主要终点
- Percent change in weight from baseline (%)
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years (as of the date of signing the Informed Consent Form (ICF)), male or female.
- •Obese (BMI ≥ 28 kg/m2) or overweight (24 kg/m2 ≤ BMI < 28 kg/m2) with at least one comorbidity.
- •Able to understand the procedures and methods in this study; willing and able to maintain a stable diet and exercise lifestyle during the research period, and willing to sign the ICF voluntarily.
- •Subjects of childbearing potential with no birth plan from the signing of ICF to 8 weeks after the last dose, willingness to take effective contraceptive measures, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of pregnancy tests at screening and Visit 2 (before randomization).
排除标准
- •Known or suspected hypersensitivity to glucagon like peptide-1 receptor agonist (GLP-1RA) drugs or excipients.
- •History of drug abuse prior to screening.
- •History of alcohol abuse within 6 months before screening.
- •Weight change of > 5.0% within 3 months before screening (self-report).
- •Presence of limb deformity or mutilation affecting height measurement.
研究组 & 干预措施
GZR18
Experimental
干预措施: GZR18 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Percent change in weight from baseline (%)
时间窗: From Week 0 to Week 48
次要结局
- Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline(From Week 0 to Week 48)
- Changes from baseline in weight(From Week 0 to Week 48)
- Changes from baseline in body mass index (BMI)(From Week 0 to Week 48)
- Changes from baseline in hip circumference(From Week 0 to Week 48)
- Changes from baseline in waist circumference(From Week 0 to Week 48)
- Changes from baseline in waist-hip ratio (waist circumference/hip circumference)(From Week 0 to Week 48)
- Treatment emergent adverse events (TEAEs)(From Week 0 to Week 48)
研究者
研究点 (1)
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