NCT05759897尚未招募2 期
A 16-week Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of HRS-7535 in Adults With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin
Shandong Suncadia Medicine Co., Ltd.0 个研究点目标入组 180 人开始时间: 2023年2月28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
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Mean Change From Baseline in HbA1c at Week 16
研究概览
简要总结
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in subjects with type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
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
- •Male or female, 18-75 age years, both inclusive;
- •Type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit;
- •HbA1c 7.5-11.0% (both inclusive) by local laboratory analysis;
- •Treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- •Body weight of at least 50 kg; and Body Mass Index (BMI) within the range of 19 to 40 kg/m2 (inclusive);
排除标准
- •Known or suspected allergy to the investigational drug or its components or excipients.
- •Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- •Have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening.
- •Proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment;
- •History or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study.
- •Discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons.
- •Previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy).
- •Pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (WOCBP) or male subject not using adequate contraceptive measures.
研究组 & 干预措施
Group A
Experimental
Subjects will receive HRS-7535 administered orally
干预措施: HRS-7535 (Drug)
Group B
Experimental
Subjects will receive HRS-7535 administered orally
干预措施: HRS-7535 (Drug)
Group C
Experimental
Subjects will receive escalated dose of HRS-7535 administered orally
干预措施: HRS-7535 (Drug)
Group D
Experimental
Subjects will receive escalated HRS-7535 administered orally
干预措施: HRS-7535 (Drug)
Group E
Placebo Comparator
Subjects will receive Placebo administered orally
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in HbA1c at Week 16
时间窗: at Week 16]
次要结局
- Proportion of subjects reaching HbA1c targets (<7.0%) at Week 16(at Week 16)
- Change From Baseline in body weight at Week 16(at Week 16)
- Change From Baseline in waist circumference at Week 16(at Week 16)
- Proportion of subjects receiving glycemic rescue medicine at Week 16(at Week 16)
- Change From Baseline in Mixed meal test at Week 16(at Week 16)
- Change From Baseline in fasting plasma glucose (FPG) at Week 16(at Week 16)
- Change From Baseline in 7-point SMBG at Week 16(at Week 16)
- A summary of adverse events, including serious adverse events (SAEs), and Hypoglycemic Event[(at Week 18)
研究者
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