NCT06904105已完成3 期
A Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HRS-7535 Tablets in Subjects With Overweight or Obesity
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 556 人开始时间: 2025年4月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- Percentage change in body weight relative to the baseline
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HRS-7535 in subjects with overweight or 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •On the day of signing the informed consent form, the age should be between 18 and 75 years old.
- •At the screening period, the Body Mass Index (BMI) should meet the criteria of ≥ 28.0 kg/m², or ≥ 24.0 kg/m² with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
- •The participant should have controlled their diet and exercise for 3 months or more prior to screening and randomization, and the weight change in the past 3 months should not exceed 5%.
- •Before the trial, the participants must voluntarily sign the informed consent form, fully understand the trial content, procedures and potential adverse reactions, and have the ability and willingness to comply with the protocol requirements to complete this study.
排除标准
- •At the screening period, relevant laboratory test results are abnormal.
- •Electrocardiogram (ECG) results at the screening period show clinically significant abnormalities.
- •Uncontrolled severe hypertension at the screening period.
- •Presence of endocrine diseases that may significantly affect the body weight.
- •History of acute or chronic pancreatitis.
- •History of significant gastrointestinal diseases.
- •Severe infections, significant trauma, or major surgery within 30 days prior to screening, as judged by the investigator.
- •Use of medications or treatments that may cause significant weight gain or loss within 90 days prior to screening.
- •Known or suspected abuse of alcohol or narcotics.
- •Any condition deemed by the investigator to be unsuitable for participation in this clinical trial.
研究组 & 干预措施
HRS-7535 Group
Experimental
干预措施: HRS-7535 Tablets (Drug)
HRS-7535 Placebo Group
Placebo Comparator
干预措施: HRS-7535 Placebo Tablets (Drug)
结局指标
主要结局
Percentage change in body weight relative to the baseline
时间窗: 44th week after administration.
Proportion of participants with a body weight reduction of ≥ 5% relative to the baseline
时间窗: 44th week after administration.
次要结局
- Proportion of participants with a body weight reduction of ≥10% and ≥15% relative to baseline(44th week and 50th week after administration)
- Change in waist circumference relative to baseline(44th week and 50th week after administration)
- Percentage change in body weight relative to baseline(50th week after administration)
- Proportion of participants with a body weight reduction of ≥5%(50th week after administration)
- Adverse events(The entire process of the trial, about 52 weeks.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and ExerciseType 2 DiabetesNCT06672172Shandong Suncadia Medicine Co., Ltd.284
已完成
3 期
A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 DiabetesType 2 DiabetesNCT06649344Fujian Shengdi Pharmaceutical Co., Ltd.884
已完成
3 期
A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With MetforminType 2 DiabetesNCT06589765Shandong Suncadia Medicine Co., Ltd.810
Unknown
3 期
A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast CancerAdvanced Breast CancerNCT03966898Jiangsu HengRui Medicine Co., Ltd.426
Unknown
3 期
A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast CancerAdvanced Breast CancerNCT03927456Jiangsu HengRui Medicine Co., Ltd.357