NCT07624071招募中1 期
A Phase 1, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ALN-6222 in Adult Participants With Obesity
Alnylam Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2026年6月4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
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
This is a first in human, randomized, double-blind (DB), placebo-controlled, single ascending dose (SAD), Phase 1 study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of ALN-6222 administered subcutaneously (SC) in adult participants 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
- •Is an adult patient with a body mass index ≥30 kg/m^2 to <40 kg/m^2
- •Has a hemoglobin A1c <6.5%
排除标准
- •Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal (ULN)
- •Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection
- •Has an estimated glomerular filtration (eGFR) of <60 mL/min/1.73m^2 at screening
- •Note: other protocol defined inclusion / exclusion criteria apply
研究组 & 干预措施
ALN-6222
Experimental
Participants will be administered a single dose of ALN-6222.
干预措施: ALN-6222 (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
Frequency of Adverse Events
时间窗: Up to 12 months
次要结局
- Concentrations of ALN-6222 in Plasma(Predose and up to 3 days postdose)
- Change from Baseline Protein Markers in Plasma(Predose and up to 12 months postdose)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
1 期
Ph 1a/1b Single Ascending Dose and Multiple Ascending Dose Study of ARQ-234EczemaAtopic Dermatitis (AD)NCT07453602Arcutis Biotherapeutics, Inc.125
招募中
1 期
A Study to Find a Suitable Dose of Exl-111 for Further ResearchAllergic DiseaseNCT07356713Excellergy Inc.70
尚未招募
1 期
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of SSS67 in Healthy Adult Participants Via Single Intravenous InfusionHealthyNCT07487545Shenyang Sunshine Pharmaceutical Co., LTD.52
招募中
1 期
Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy SubjectsHealth Services ResearchNCT07535099Beijing InnoCare Pharma Tech Co., Ltd.104
已完成
1 期
A First-in-Human Study of KINE-101 in Healthy VolunteersHealthy VolunteersNCT07343323Kine Sciences Co., Ltd.40