A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of ALN-2232 as Monotherapy and Co-initiated With Tirzepatide in Adult Participants With Obesity
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 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, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of ALN-2232 in patients with obesity
- evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 in patients with obesity
- evaluate the safety, tolerability, efficacy, PK, and PD of multiple doses of ALN-2232 co-initiated with tirzepatide in patients with obesity
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
- •Has a body mass index (BMI) of ≥30 kg/m^2 and <40 kg/m^2
- •Has a hemoglobin A1c (HbA1c) <6.5%
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 for chronic weight management or antidiabetic medications
- •Note: other protocol defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part C: ALN-2232
Participants will be administered multiple doses of ALN-2232
干预措施: ALN-2232 (Drug)
Part A: ALN-2232
Participants will be administered a single dose of ALN-2232
干预措施: ALN-2232 (Drug)
Part B: Placebo
Participants will be administered multiple doses of placebo
干预措施: Placebo (Drug)
Part A: Placebo
Participants will be administered a single dose of placebo
干预措施: Placebo (Drug)
Part B: ALN-2232
Participants will be administered multiple doses of ALN-2232
干预措施: ALN-2232 (Drug)
Part C: Placebo
Participants will be administered multiple doses of placebo
干预措施: Placebo (Drug)
Part C: Tirzepatide
Participants will be administered multiple doses of tirzepatide once weekly
干预措施: Tirzepatide (Drug)
Part C: ALN-2232
Participants will be administered multiple doses of ALN-2232
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Part A: Frequency of Adverse Events (AEs)
时间窗: Up to 12 months
Part B: Percent Change from Baseline in Body Weight
时间窗: Baseline up to Month 6
Part C: Percent Change from Baseline in Body Weight
时间窗: Baseline up to Month 6
次要结局
- Part A: Change from Baseline in Proteins in Adipose Tissue(Baseline up to Month 12)
- Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma(Predose and up to 15 days postdose)
- Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma(Predose and up to 15 days postdose)
- Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma(Predose and up to 15 days postdose)
- Part A: Fraction of ALN-2232 excreted in urine(Predose and up to 8 days postdose (fe))
- Part A: Percent Change from Baseline in Body Weight(Baseline up to Month 12)
- Part B and Part C: Concentrations of ALN-2232 in Plasma(Predose and up to 6 months postdose)
- Part B and Part C: Percent Change from Baseline in Body Weight(Baseline up to Month 12)
- Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass(Baseline up to Month 12)