NCT07156500尚未招募3 期
A Multicenter, Randomized, Double-Blind, Placebo- Parallel Controlled, Phase III Study to Evaluate the Efficacy and Safety of HS-20094 Injection in Subjects With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2025年9月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 ≤10.5% 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 4 weeks before screening.
- •Participated in clinical trials of any drug or medical device within 12 weeks 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 A
Experimental
干预措施: HS-20094 Injection (Drug)
Group B
Placebo Comparator
干预措施: HS-20094 Placebo Injection (Drug)
Group C
Experimental
干预措施: HS-20094 Injection (Drug)
Group D
Placebo Comparator
干预措施: HS-20094 Placebo Injection (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Week 0 to Week 44
Change from baseline in HbA1c after 44 weeks of treatment
次要结局
- Proportion of subjects with HbA1c<7.0% and ≤6.5%(Week 0 to Week 52)
- Change in FPG(Week 0 to Week 52)
- Change in body weight(Week 0 to Week 52)
- Proportion of subjects with weight loss ≥5% and ≥10%(Week 0 to Week 52)
- Incidence and severity of adverse events(Week 0 to Week 52+4 weeks follow-up)
- Change in HbA1c(Week 0 to Week 52)
研究者
研究点 (1)
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