NCT06650007已完成3 期
A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone
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
- 218
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The primary objective of this study is to evaluate the effectiveness of HRS9531 compared to placebo in controlling blood glucose levels after 36 weeks of treatment
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, Age ≥18 years at the time of signing informed consent.
- •Diagnosed with type 2 diabetes mellitus (T2DM) for at least 90 days prior to day of screening.
- •Treatment with Diet and Exercise alone at least 90 days prior to day of screening.
- •7.5% ≤ HbA1c ≤10.0% at screening.
排除标准
- •Uncontrollable hypertension(with or without antihypertensive treatment) : systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg at screening.
- •Diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes.
- •History of significant hematological disorders (e.g., sickle cell disease, hemolytic anemia, myelodysplastic syndrome, etc.) or other conditions causing hemolysis or instability of red blood cells (e.g., malaria, hypersplenism, etc.).
- •Presence of an endocrine disorder or history that may significantly affect bady weight(e.g., Cushing's syndrome, hypothyroidism or hyperthyroidism, except hypothyroidism if thyroid hormone replacement dose has been stable for at least 6 months) ；
- •Severe infection, severe trauma, or moderate-to-major surgery within 1 month before screening.
- •Participated in clinical trials of any drug or medical device within 3 months prior to screening, and participation in clinical trials is defined as signing informed consent and using investigational drugs (including placebo) or investigational medical devices; Or is still in the trial drug within 5 half-lives (whichever is Longer).
研究组 & 干预措施
Group B
Placebo Comparator
干预措施: HRS9531 Placebo Injection (Drug)
Group D
Placebo Comparator
干预措施: HRS9531 Placebo Injection (Drug)
Group A
Experimental
干预措施: HRS9531 Injection (Drug)
Group C
Experimental
干预措施: HRS9531 Injection (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: from baseline to 36 weeks treatment
次要结局
- Proportion of subjects with HbA1c<7.0% and ≤6.5%(from baseline to 36 weeks treatment)
- Change in FPG(from baseline to 36 weeks treatment)
- Change in body weight(from baseline to 36 weeks treatment)
- Proportion of subjects with HbA1c<7.0% and weight loss ≥5%(from baseline to 36 weeks treatment)
研究者
研究点 (1)
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