NCT06256562已完成2 期
A Multicenter, Randomized, Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety 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 340 人开始时间: 2023年6月8日最近更新:
适应症
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
- 340
- 试验地点
- 1
- 主要终点
- Percent (%) change from baseline in body weight at the end of the study (W30)
研究概览
简要总结
This study is a multicenter, randomized, placebo-controlled phase II clinical study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of GZR18 injection in Chinese adult obese/overweight 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18-75 years (inclusive).
- •Obese subjects (BMI≥28 kg/m2), Or overweight subjects (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.
排除标准
- •Limb deformities or defects affecting height and body weight measurement.
- •Pregnant or lactating women, men or women of reproductive potential unwilling to use contraception throughout the study and for 6 months after the last dose of investigational drug.
- •History of drug abuse within 1 year before screening, or positive results in drug abuse screening during screening or before randomization.
- •Alcohol abuse history within 6 months prior to screening.
- •Subjects who are known or suspected to be allergic to GLP-1 drugs or excipients.
- •Subjects with an absolute weight change greater than 5.0% due to any reason within the 3 months prior to 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
Percent (%) change from baseline in body weight at the end of the study (W30)
时间窗: 30 weeks
次要结局
- Proportion of subjects who achieved (yes/no) body weight reduction ≥5%, 10%, 15%, 20% from baseline.(30 weeks)
- Weight, waist circumference, waist-to-hip ratio (waist circumference/hip circumference), and body mass index (BMI)(30 weeks)
- Percentage (%) of weight(33 weeks)
- Glucose metabolism indicators: glycated hemoglobin A1C (HbA1c), fasting plasma glucose (FPG), fasting insulin, insulin resistance index (HOMA-IR), and islet β cell function (HOMA-β)(30 weeks)
- Cardiovascular disease risk factors: blood pressure (SBP and DBP), pulse, total cholesterol (TC), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C), and triglycerides (TG)(30 weeks)
- Patient-reported weight-related quality of life scores: IWQoL-Lite-CT and SF-36 scale(30 weeks)
- Anti-drug antibodies (ADAs) for GZR18 and neutralizing antibodies (NAbs) following GZR18 Injection(33 weeks)
- AUClast, AUC0-inf, Tmax, λz, t1/2, tlag, CL/F, Vz/F, AUC%extra, MRT, Css_min, Css_max, Css_av, DF, Css_min(30 weeks)
- The number of adverse events (AEs)/serious adverse events (SAEs) /AEs of special interest (AESIs) that occurred during the study.(33 weeks)
- Vital signs, physical examination, 12-lead Electrocardiogram (ECG), and clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood amylase, blood lipase, coagulation function, calcitonin,TSH/FT3/FT4(33 weeks)
- Subject's mental health status (assessed by using the Columbia-Suicide Severity Rating Scale and Patient Health Questionnaire (PHQ-9))(33 weeks)
研究者
研究点 (1)
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