NCT07836270尚未招募3 期
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Safety and Efficacy of Ecnoglutide Injection in Overweight or Obese Chinese Adolescents (SLIMMER-YOUNG)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Percent change in Body Mass Index (BMI)
研究概览
简要总结
The aim of the study is to evaluate the safety and efficacy of Ecnoglutide injection in overweight or obese Chinese adolescents
详细描述
In this study, eligible participants will be randomized into one of the three cohorts in a 3:1 ratio to receive either once-weekly subcutaneous Ecnoglutide injection or placebo, for up to 52 weeks
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At screening, the BMI meets the obesity criteria specified in 'WS/T586-2018 Screening for Overweight and Obesity in School-Aged Children and Adolescents', or it meets the overweight criteria and is accompanied by at least one weight-related comorbidity: hyperglycemia, hypertension, dyslipidemia, fatty liver, obstructive sleep apnea syndrome, etc.
- •Participant with body weight loss <5% by diet and exercise for at least 3 months before screening (per self, parental/legal report).
排除标准
- •Pre-adolescent participants (Tanner phase 1);
- •History of receiving weight loss surgery or plan to undergo weight loss surgery during the study period (excluding acupuncture-based weight loss, liposuction, or abdominal fat removal procedures conducted more than 1 year prior to screening);
- •Known secondary obesity, including but not limited to that resulting from: hypercortisolism (e.g. Cushing's syndrome), pituitary or hypothalamic lesions, or monogenic obesity, etc.;
- •Diagnosis with any type of diabetes;
- •History of acute or chronic pancreatitis, history of gallbladder disease or pancreatic injury;
- •History of using any approved or unapproved drugs for weight loss, antidiabetic drugs, long-term systemic glucocorticoids (more than 14 days), within 3 months prior to screening;
研究组 & 干预措施
placebo
Placebo Comparator
once weekly
干预措施: placebo with matching volume (Drug)
Ecnoglutide Injection Dose 2
Experimental
once weekly
干预措施: Ecnoglutide Injection (Drug)
Ecnoglutide Injection Dose 1
Experimental
once weekly
干预措施: Ecnoglutide Injection (Drug)
Ecnoglutide Injection Dose 3
Experimental
once weekly
干预措施: Ecnoglutide Injection (Drug)
结局指标
主要结局
Percent change in Body Mass Index (BMI)
时间窗: Baseline, week 40
次要结局
- Percentage of participants with ≥5% of BMI reduction(Baseline, week 40 and week 52)
- Percentage of participants with ≥10% of BMI reduction(Baseline, week 52)
- Change in BMI(Baseline, week 52)
- Percentage of participants with ≥15% of BMI reduction(Baseline, week 52)
- Percentage of participants with ≥20% of BMI reduction(Baseline, week 52)
- Change in body weight(Baseline, week 52)
- Change in Glycated Hemoglobin (HbA1c)(Baseline, week 52)
- Change in Fasting Plasma Glucose (FPG)(Baseline, week 52)
- Change in Fasting Insulin(Baseline, week 52)
- Change in Homeostasis Model Assessment 2 - Insulin Resistance (HOMA2-IR)(Baseline, week 52)
- Change in Homeostasis Model Assessment 2 - Beta Cell Function (HOMA2-β)(Baseline, week 52)
- Change in lipid profile(Baseline, week 52)
- Change in liver enzymes(Baseline, week 52)
- Adverse events(From week1 to week 57)
- Trough concentration of ecnoglutide(From baseline to week 57 (EOS))
研究者
研究点 (1)
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