A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (Safety and Tolerability)
研究概览
简要总结
The main purpose of this study is to assess the safety and tolerability of multiple subcutaneous injections of HRS9531 in patients with type 2 diabetes mellitus who have suboptimal glycaemic control after conventional lifestyle or metformin intervention.
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
- Double (Participant, Investigator)
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
- •Males and infertility females, 18-65 years of age, inclusive, on the date of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus (T2DM) for at least 6 months.
- •Treated with conventional lifestyle intervention alone or stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening.
- •7.0% ≤ HbA1c ≤10.5% at screening.
排除标准
- •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.
- •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.) or episode of severe hypoglycaemic events within 12 months prior to screening.
- •Have a presence of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy requiring treatment during the trial;
- •Participants in clinical trials of any drug or medical device in the 3 months prior to screening.
- •Breast-feeding women.
- •The investigator considers that the subject has any other factors that would make it inappropriate to participate in this study.
研究组 & 干预措施
Group B
Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
干预措施: Placebo (Drug)
Group C
Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
干预措施: HRS9531 (Drug)
Group C
Participants receive high dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
干预措施: Placebo (Drug)
Group D
Participants receive Dulaglutide 1.5 mg by multiple subcutaneous injection
干预措施: Dulaglutide Injection (Drug)
Group A
Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
干预措施: HRS9531 (Drug)
Group A
Participants receive low dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
干预措施: Placebo (Drug)
Group B
Participants receive medium dose level of HRS9531 or matched placebo administrated by multiple subcutaneous injection
干预措施: HRS9531 (Drug)
结局指标
主要结局
Incidence of Adverse Events (Safety and Tolerability)
时间窗: Screening period up to Day 62
A summary of adverse events, including serious adverse events (SAEs) and Hypoglycemic Events
次要结局
- Area Under the Concentration Versus Time Curve (AUC) of HRS9531(Start of Treatment up to Day 62)
- Change from Baseline in Fasting Blood Glucose (FBG)(Baseline up to Day 62)
- Maximum Concentration (Cmax) of HRS9531(Start of Treatment up to Day 62)
- Immunogenicity: anti-HRS9531 antibody(Start of Treatment up to Day 62)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline up to Day 29)
- Change from Baseline in Weight(Baseline up to Day 62)