NCT07559136招募中1 期
A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of HRS9531 Injection in Chinese Adolescents With Obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
The aim of this trial is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS9531 injection compared with placebo in adolescents with 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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects who are aged ≥12 years and <18 years at the time of signing the informed consent;
- •At screening, the BMI meets the obesity criteria according to "WS/T586-2018 Screening Criteria for Overweight and Obesity in School-age Children and Adolescents";
- •Subjects who have maintained a controlled diet and exercise for at least 12 weeks prior to screening, with no more than a 5% decrease in BMI (as reported by the subject, parent, or legal guardian);
排除标准
- •Presence of clinically significant lab results at screening visit;
- •Uncontrollable hypertension;
- •Medical history or illness that affects your weight;
- •History of diabetes;
- •Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
- •Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
- •Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- •Pre-adolescent participants (Tanner phase I);
- •Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
- •Surgery is planned during the tria;
- •Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；
- •In the investigator's judgment, there are circumstances that affect subject safety or any other conditions that interfere with the evaluation of the test results.
研究组 & 干预措施
Treatment group C: HRS9531 injection or Placebo
Experimental
干预措施: HRS9531 injection；Placebo (Drug)
Treatment group A: HRS9531 injection or Placebo
Experimental
干预措施: HRS9531 injection；Placebo (Drug)
Treatment group B: HRS9531 injection or Placebo
Experimental
干预措施: HRS9531 injection；Placebo (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: up to Week 28
次要结局
- Maximum concentration (Cmax) of HRS9531(up to Week 28)
- Trough concentration (Ctrough) of HRS9531(up to Week 28)
- Area under the curve from time zero to end of dosing interval (AUC0-tau)(up to Week 28)
- Changes from baseline in BMI(up to Week 24)
- Change from baseline in body weight(up to Week 24)
- Change from baseline in waist circumference(up to Week 24)
- Anti-HRS9531 antibodies (ADA)(up to Week 28)
研究者
研究点 (2)
Loading locations...
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