NCT07465224招募中2 期
A Randomized, Double-blind, Placebo-controlled Study Investigating the Effect of ALN-4324 on Insulin Sensitivity in Patients With Type 2 Diabetes Mellitus
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年1月15日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from Baseline in M-value
研究概览
简要总结
The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM
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
- Triple (Participant, Care Provider, 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
- •Is an adult patient with a confirmed diagnosis of T2DM
- •Has a body mass index (BMI) of ≥23 kg/m^2 to ≤39.9 kg/m^2
- •Has a hemoglobin A1c (HbA1c) ≥6.5% to <10.5%
- •Is on a stable dose of metformin, sodium-glucose cotransporter 2 inhibitor (SGLT2i), or dipeptidyl peptidase-4 inhibitor (DPP4i)
排除标准
- •Has any clinically significant concomitant disease, medical condition, or abnormal laboratory finding that could compromise participant safety or confound interpretation of study results
- •Receiving therapies known to interfere with glucose or insulin metabolism other than current treatment for T2DM or birth control methods
- •Note: other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
ALN-4324
Experimental
Participants will be administered a single dose of ALN-4324.
干预措施: ALN-4324 (Drug)
Placebo
Placebo Comparator
Participants will be administered a single dose of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in M-value
时间窗: Baseline up to Month 3
M-value is measured as the glucose infusion rate at steady state
次要结局
- Frequency of Adverse Events (AEs)(Up to Month 9)
- Change from Baseline in M-value(Baseline up to Month 6)
- Change from Baseline in M/I(Baseline up to Month 6)
- Change from Baseline in Endogenous Glucose Production (EGP)(Baseline up to Month 6)
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline up to Month 6)
研究者
研究点 (1)
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