NCT06649344已完成3 期
A Phase III,Multicenter,Randomized,Open-label,Parallel-controlled Study Comparing the Efficacy and Safety of HRS9531 With Semaglutide in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Metformin Monotherapy or in Combination With SGLT2 Inhibitors
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
- 884
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HRS9531 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Semaglutide QW for 36 weeks and 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
- None
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
- •Diagnosed with type 2 diabetes ≥ 90 days；
- •Stable daily dose(s) for ≥3months prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;
- •Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
- •Female patients of childbearing potential and male patients must agree to use highly effective contraception during the trial and for at least 2 months after the last dose of the investigational medicinal drug. Female patients of childbearing potential must test negative for pregnancy at Visit 1 and not be breastfeeding.
排除标准
- •Known or suspected allergy or intolerance to the investigational medicinal products or related products；
- •Acute complications of diabetes occurred during the previous 6 months；
- •Serious chronic complications of diabetes in the past；
- •Use other antidiabetic drugs for ≥3months prior to screening ;
- •Before screening, have disease or treatment that may affect weight; or any previous condition that may affect gastric emptying； or gastrointestinal surgery;
- •Participation in any clinical trial of an approved or non-approved investigational product/treatment within the last 3 months or 5 half-lives, whichever is longer, prior to screening;
- •Any conditions that the Investigator judges might not be suitable to participate in the trial.
研究组 & 干预措施
Treatment group A
Experimental
HRS953-low dose
干预措施: HRS9531 Injection (Drug)
Treatment group B
Experimental
HRS9531-high dose
干预措施: HRS9531 Injection (Drug)
Treatment group C
Active Comparator
Semaglutide-1mg
干预措施: Semaglutide Injection (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0 to Week 36
Change from baseline in Glycosylated Haemoglobin after 36 weeks of treatment.
次要结局
- Change in body weight(Week 0 to Week 36)
- Proportion of Subjects with HbA1c≤6.5%(Week 0 to Week 36)
- Proportion of Subjects with HbA1c<7%(Week 0 to Week 36)
- Change in FPG (fasting plasma glucose)(Week 0 to Week 52)
- 7-points SMPG profiles(Week 0 to Week 36)
- Incidence and severity of adverse events(Week 0 to Week 52+4 weeks follow-up)
- Change in FPG (fasting plasma glucose)(Week 0 to Week 36)
研究者
研究点 (2)
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