NCT06671821已完成2 期
HRS-7535-202 Follow-up Study: A Long-term Evaluation of Safety, Tolerability, and Efficacy in Obese Subjects (Open-label, Extension Trial)
Shandong Suncadia Medicine Co., Ltd.1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年11月20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
- 81
- 试验地点
- 1
- 主要终点
- Number of participants with Treatment-emergent Adverse Event(AE)
研究概览
简要总结
The Objective of this trial is to evaluate the long-term safety, tolerability, weight loss efficacy and metabolic benefits of HRS-7535 tablets inobesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects, 18-65 years of age at the time of signing informed consent;
- •Subjects who have completed the entire 36-week treatment course of the HRS-7535-202 trial.
- •Subjects who have a full understanding of the trial content, processes, and possible adverse reactions, and are capable and willing to comply with the protocol requirements to complete this study.
排除标准
- •Participants with poor compliance during the 36-week open-label extension treatment of the HRS-7535-202 trial;
- •Pregnant, lactating, planning to conceive during the trial period, or fertile subjects unwilling to take effective contraceptive measures during the trial period.
- •Any other conditions deemed unsuitable for participation in this clinical trial by the investigator.
研究组 & 干预措施
Group A
Experimental
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
干预措施: HRS-7535 (Drug)
Group B
Experimental
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
干预措施: HRS-7535 (Drug)
Group C
Experimental
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
干预措施: HRS-7535 (Drug)
Group D
Experimental
Subjects will receive escalated dose of HRS-7535 or maximum tolerated dose orally
干预措施: HRS-7535 (Drug)
结局指标
主要结局
Number of participants with Treatment-emergent Adverse Event(AE)
时间窗: During the 32-week open-label extension treatment period
次要结局
- Percentage change in body weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;(from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;)
- Proportion of subjects with ≥5%, ≥10%, and ≥15% weight reduction from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;(from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;)
- Changes in weight from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;(from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;)
- Changes in waist circumference from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;(from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;)
- Changes in body mass index (BMI) from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;(from baseline before HRS-7535 tablet treatment to Week 32 of open-label extension treatment;)
研究者
研究点 (1)
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