NCT07156539尚未招募3 期
A Study of HS-20094 Versus Dulaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabete
Jiangsu Hansoh Pharmaceutical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 546 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
- 546
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of HS-20094 once weekly (QW) in subjects with type 2 diabetes mellitus not adequately controlled with metformin monotherapy or in combination with SGLT2 inhibitors compared to Dulaglutide QW for 44 weeks and 52 weeks.
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
- None
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.
- •Stable daily dose(s) for ≥90 days prior to screening of : 1) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily). 2) Any metformin formulations ≥1500 mg daily or maximum tolerated (≥1000mg daily) with one type of SGLT-2 inhibitors;
- •Glycated hemoglobin was 7.5% ≤HbA1c ≤11.0%;
- •BMI ≥ 23 kg/m2.
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
Treatment Group B
Experimental
HS-20094-high dose
干预措施: HS-20094 Injection (Drug)
Treatment Group C
Active Comparator
Dulaglutide -1.5mg
干预措施: Dulaglutide Injection (Drug)
Treatment Group A
Experimental
HS-20094-low dose
干预措施: HS-20094 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)
- Change in HbA1c(Week 0 to Week 52)
- Incidence and severity of adverse events(Week 0 to Week 52+4 weeks follow-up)
研究者
研究点 (2)
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