NCT06845202进行中（未招募）1 期
A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)
Alnylam Pharmaceuticals23 个研究点 分布在 6 个国家目标入组 105 人开始时间: 2025年3月3日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 23
- 主要终点
- Part A: Frequency of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to:
- evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324
- evaluate the efficacy, safety, tolerability, PK, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a body mass index (BMI) of ≥27 kg/m^2 and <40 kg/m^2
- •Is an adult patient with a confirmed diagnosis of T2DM
- •Has a hemoglobin A1c (HbA1c) ≥7% to <10.5%
- •Has a BMI of ≥25 kg/m^2 and <45 kg/m^2
- •Is on a stable dose of either metformin or metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i)
排除标准
- •Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- •Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i
- •Note: other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part B: Placebo
Placebo Comparator
Participants will be administered multiple doses of placebo
干预措施: Placebo (Drug)
Part A: Placebo
Placebo Comparator
Participants will be administered a single dose of placebo.
干预措施: Placebo (Drug)
Part A: ALN-4324
Experimental
Participants will be administered a single dose of ALN-4324.
干预措施: ALN-4324 (Drug)
Part B: ALN-4324
Experimental
Participants will be administered multiple doses of ALN-4324
干预措施: ALN-4324 (Drug)
结局指标
主要结局
Part A: Frequency of Adverse Events (AEs)
时间窗: Up to 9 months
Part B: Frequency of Adverse Events
时间窗: Up to 12 months
Part A: Frequency of Adverse Events (AEs)
时间窗: Up to 9 months
Part B: Frequency of Adverse Events
时间窗: Up to 12 months
次要结局
- Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma(Predose and up to 3 days postdose)
- Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma(Predose and up to 3 days postdose)
- Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma(Predose and up to 3 days postdose)
- Part A: Fraction of ALN-4324 excreted in urine(Predose and up to 24 hours postdose (fe))
- Part B: Concentrations of ALN-4324 in Plasma(Predose and up to 4 hours postdose)
- Part B: Change from Baseline in HbA1c(Baseline up to 6 months)
- Part B: Response to Glucose Tolerance Test(Predose and up to 2 hours postdose)
研究者
研究点 (23)
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