NCT07843862尚未招募2 期
A Phase II, Multicenter, Double-Blind, Randomized, Placebo- and Active-Controlled, Parallel-Group Clinical Trial Evaluating the Efficacy and Safety of HRS-4729 Injection in Participants With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Change From Baseline in HbA1c
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of HRS-4729 Injection in participants with type 2 diabetes who failed to achieve adequate glycemic control on diet and exercise alone or on a stable dose of metformin.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 2 Diabetes
- •Treated with diet and exercise alone or with a stable dose of metformin
- •Have an HbA1c value at screening of ≥7.5% and ≤10.5%
排除标准
- •Have uncontrolled hypertension
- •Have Type 1 Diabetes, or specific types of diabetes
- •History of acute diabetic complications or severe hypoglycemic events
- •History of severe chronic diabetic complications, or non-proliferative diabetic retinopathy requiring treatment
- •History of any condition affecting gastric emptying, long-term use of medications directly affecting gastrointestinal motility, severe gastrointestinal disease, or prior gastrointestinal surgery
- •History or known history of acute or chronic pancreatitis, or pancreatic injury
- •History or known history of acute cholecystitis, or symptomatic/treatment-requiring gallbladder disease
- •Personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia type 2 (MEN2)
研究组 & 干预措施
Treatment group A
Experimental
干预措施: HRS-4729 Injection (Drug)
Treatment group B
Experimental
干预措施: HRS-4729 Injection (Drug)
Treatment group C
Experimental
干预措施: HRS-4729 Injection (Drug)
Treatment group D
Experimental
干预措施: HRS-4729 Injection (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Mazdutide
Active Comparator
干预措施: Mazdutide (Drug)
结局指标
主要结局
Change From Baseline in HbA1c
时间窗: Baseline, Week 28
次要结局
- Change From Baseline in Fasting Plasma Glucose(Baseline, Week 28)
- TEAEs(Baseline, Week 32)
- Percentage of Participants Reaching HbA1c <7.0%, ≤6.5%, and <5.7%(Baseline, Week 28)
- Percent Change From Baseline in Body Weight(Baseline, Week 28)
研究者
研究点 (2)
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