NCT05761301终止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-KHK in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-KHK in Obese Patients With Type 2 Diabetes Mellitus (T2DM)
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2023年3月10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
- 终止
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Part A: Frequency of Adverse Events
研究概览
简要总结
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 是
入选标准
- •Stable euthyroid status (no known changes in thyroid function; stable hormone replacement for at least 4 months) at screening
- •Part A: body mass index (BMI) ≥27 kg/m^2 and ≤34.9 kg/m^2
- •Part B: BMI ≥30 kg/m^2 to ≤39.9 kg/m^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to <10%
- •Part B: Confirmed T2DM diagnosis
排除标准
- •Parts A and B: has received an investigational agent within the last 30 days
- •Part A: History of Type 1 or Type 2 diabetes
- •Part B: History of Type 1 diabetes
研究组 & 干预措施
Part A: ALN-KHK
Experimental
Participants will be administered a single dose of ALN-KHK.
干预措施: ALN-KHK (Drug)
Part A: Placebo
Placebo Comparator
Participants will be administered a single dose of placebo.
干预措施: Placebo (Drug)
Part B: ALN-KHK
Experimental
Participants will be administered a multiple doses of ALN-KHK.
干预措施: ALN-KHK (Drug)
Part B: Placebo
Placebo Comparator
Participants will be administered a multiple doses of placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Part A: Frequency of Adverse Events
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: Fraction of ALN-KHK Excreted in the Urine (fe) and Potential Major Metabolite(s)(Postdose on Day 1)
- Part B: Absolute Change from Baseline in Hemoglobin A1C (HbA1c) at 6 Months(Baseline and Month 6)
- Part B: Fasting Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)(Month 4)
- Part A: Area Under the Concentration-time Curve (AUC) of ALN-KHK and Potential Major Metabolite(s)(Up to 2 Days following dosing on Day 1)
- Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-KHK and Potential Major Metabolite(s)(Up to 2 Days following dosing on Day 1)
- Part A: Time to Maximum Observed Plasma Concentration (Tmax) of ALN-KHK and Potential Major Metabolite(s)(Up to 2 Days following dosing on Day 1)
- Part A: Percent Change from Baseline in Urinary Fructose in Response to a Fructose Tolerance Test(Baseline up to Month 6)
- Part A: Percent Change from Baseline in Circulating Fibroblast Growth Factor 21 (FGF21) in Response to a Fructose Tolerance Test(Baseline up to Month 6)
- Part B: Plasma Concentrations of ALN-KHK and Potential Major Metabolite(s)(Day 1 and Month 3)
- Part A: Percent Change from Baseline in Circulating Fructose in Response to a Fructose Tolerance Test(Baseline up to Month 6)
- Parts A and B: Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) in Response to a Glucose Tolerance Test(Part A: Screening up to Month 3; Part B: Month 4)
- Parts A and B: Glucose and Insulin AUC in response to Tolerance Test(Part A: Screening up to Month 3; Part B: Month 4)
研究者
研究点 (1)
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