NCT06396429已完成3 期
Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 567
- 试验地点
- 1
- 主要终点
- Percentage change from baseline in weight after 48 weeks of treatment
研究概览
简要总结
The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Able and willing to provide a written informed consent.
- •Male or female subjects, ≥18 years of age at the time of signing informed consent.
- •At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
- •Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
- •Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.
排除标准
- •Presence of clinically significant lab results at screening visit;
- •Uncontrollable hypertension;
- •PHQ-9 score ≥15;
- •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;
- •History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
- •Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin、 in-situ cancer of the cervix and in-situ cancer of the prostate;
- •Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
- •Known or suspected history of alcohol and/or substance abuse or drug abuse;
- •History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.
- •Have received or plan to have an organ or bone marrow transplant during the study.
- •The presence of any blood disorders that may interfere with HbA1c testing.
- •Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.
- •Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- •Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;
- •Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
- •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 (medical, psychological, social, or geographical factors, etc.) 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 A: HRS9531 injection
Experimental
干预措施: HRS9531 injection (Drug)
Treatment group B: HRS9531 injection
Experimental
干预措施: HRS9531 injection (Drug)
Treatment group C: HRS9531 injection
Experimental
干预措施: HRS9531 injection (Drug)
Placebo injection
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change from baseline in weight after 48 weeks of treatment
时间窗: Baseline, Week 48
Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment
时间窗: Week 48
次要结局
- Change from baseline in BMI after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in Triglycerides after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment(Baseline, Week 48)
- Change in scores of SF-36 V2 from baseline after 48 weeks of treatment(Baseline, Week 48)
- Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment(Week 48)
- Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment(Week 48)
- Change from baseline in Total Cholesterol after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in weight after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in waist circumference after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in systolic blood pressure after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in diastolic blood pressure after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment(Baseline, Week 48)
- Change from baseline in fasting serum insulin after 48 weeks of treatment(Baseline, Week 48)
- Number of AEs during the trial(week 0 to week 52)
研究者
研究点 (1)
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