NCT07139535尚未招募3 期
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
Guangdong Raynovent Biotech Co., Ltd1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2025年8月31日最近更新:
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
- 350
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
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
- •Have been diagnosed with type 2 diabetes mellitus (T2DM)
- •Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.
- •Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
- •Be of stable weight (±5%) for at least 12 weeks before screening
排除标准
- •Have type 1 diabetes mellitus
- •Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;
- •History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
- •Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose <3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;
- •History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
- •Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);
- •Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).
研究组 & 干预措施
6mg RAY1225
Experimental
Participants received 6 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.
干预措施: RAY1225 (Drug)
3mg RAY1225
Experimental
Participants received 3 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.
干预措施: RAY1225 (Drug)
9mg RAY1225
Experimental
Participants received 9 milligrams (mg) of RAY1225 as subcutaneous injection once every two week.
干预措施: RAY1225 (Drug)
Placebo
Placebo Comparator
Participants received placebo as subcutaneous injection once every two week.
干预措施: placebo (Drug)
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline,36 Week
HbA1c is the glycosylated fraction of hemoglobin A.
次要结局
- Percentage of Participants Achieving an HbA1c Target Value of <7%(Baseline,36 Week)
- Percentage of Participants With HbA1c Target Value of <6.5%(Baseline,36 Week)
- Mean change in fasting serum glucose(Baseline,36 Week)
- Proportion of patients who achieved weight loss of >5%, >10%, and >15% from baseline(Baseline,36 Week)
研究者
研究点 (1)
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