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临床试验/NCT06784349
NCT06784349已完成1 期

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ALN-APOC3 in Adult Participants With Dyslipidemia

Regeneron Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2025年1月27日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
32
试验地点
1
主要终点
Incidence of Treatment Emergent Adverse Events (TEAEs)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is researching an experimental drug called ALN-APOC3 (called "study drug"). The study is focused on participants who have dyslipidemia (abnormal amounts of fats in the blood, including triglycerides and cholesterol), but who are otherwise healthy.

The aim of the study is to see how safe and effective the study drug is.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in the blood at different times
  • How the study drug changes lipid levels in the blood

详细描述

The study will be conducted in 2 parts, Part A and Part B. Participants in Part A will be excluded from participating in Part B.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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

  • •Judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECG's) and laboratory safety testing, as defined in the protocol
  • •Participants can enter the study under one of the following options, as defined in the protocol:
  • •Currently not taking statin and have not been on statin therapy for the 3 months prior to screening, or
  • •On a stable dose of statin, taken continuously for 3 months
  • •Fasting triglycerides concentrations ≥100 and <500 mg/dL (1.13 to 5.65 mmol/L) during screening visit, as defined in the protocol
  • •Fasting LDL-C ≥70 (1.81 mmol/L) if on stable statin therapy OR if not on statin treatment, as defined in the protocol

排除标准

  • •History of clinically significant cardiovascular (other than dyslipidemia), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disease, or any other concern, as assessed by the investigator that may confound the results of the study or poses an additional risk to the participant by study participation
  • •Was hospitalized (ie, >24 hours) for any reason within 30 days of the screening visit
  • •Is positive for Human Immunodeficiency Virus (HIV) or Hepatitis B surface Antigen (HBsAg) at the screening visit, as defined in the protocol
  • •Is positive for hepatitis C antibody and positive for qualitative Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) test at the screening visit
  • •Any malignancy, except for non-melanoma skin cancer or cervical/anus in-situ, that have been resected with no evidence of metastatic disease for 3 years prior to the screening visit
  • •NOTE: Other protocol defined inclusion/exclusion criteria apply

研究组 & 干预措施

ALN-APOC3 Ascending Cohorts

Experimental

Part A: Ascending Cohorts Randomized as described in the protocol May include optional cohorts

干预措施: ALN-APOC3 (Drug)

ALN-APOC3 Ascending Cohorts

Experimental

Part A: Ascending Cohorts Randomized as described in the protocol May include optional cohorts

干预措施: Matching Placebo (Drug)

Placebo

Placebo Comparator

Part A and Part B:

Randomized as described in the protocol

干预措施: Matching Placebo (Drug)

ALN-APOC3 low-dose

Experimental

Part B: Parallel Arm Randomized as described in the protocol

干预措施: ALN-APOC3 (Drug)

ALN-APOC3 medium-dose

Experimental

Part B: Parallel Arm Randomized as described in the protocol

干预措施: ALN-APOC3 (Drug)

ALN-APOC3 high-dose

Experimental

Part B: Parallel Arm Randomized as described in the protocol

干预措施: ALN-APOC3 (Drug)

结局指标

主要结局

Incidence of Treatment Emergent Adverse Events (TEAEs)

时间窗: Through Week 44

Severity of TEAEs

时间窗: Through Week 44

Percent changes in fasting concentrations of High-Density Lipoprotein Cholesterol (HDL-C)

时间窗: Baseline to week 24

Part B Only

次要结局

  • Absolute change in fasting concentrations of APOC3(Baseline to Week 24)
  • Urinary excretion of combined ALN-APOC3 and metabolites(Through 24 Hours, After Treatment)
  • Concentration of combined ALN-APOC3 and metabolites in plasma(Through Week 44)
  • Percent change in fasting concentrations of APOC3(Baseline to Week 24)
  • Percent change in fasting concentrations of HDL-C(Baseline to Week 12)
  • Absolute change in fasting concentrations of HDL-C(Baseline to Week 24)
  • Percent change in fasting concentrations of Low-Density Lipoprotein Cholesterol (LDL-C)(Baseline to Week 12)
  • Absolute change in fasting concentrations of LDL-C(Baseline to Week 24)
  • Percent change in fasting concentrations of LDL-C(Baseline to Week 24)
  • Percent change in fasting concentrations of Triglycerides (TG)(Baseline to Week 12)
  • Absolute change in fasting concentrations of TG(Baseline to Week 24)
  • Percent change in fasting concentrations of TG(Baseline to Week 24)
  • Percent change in fasting concentrations of non-HDL-C(Baseline to Week 24)
  • Absolute change in fasting concentrations of non-HDL-C(Baseline to Week 24)
  • Percent change in fasting concentrations of Apolipoprotein-B (APOB)(Baseline to Week 12)
  • Absolute change in fasting concentrations of APOB(Baseline to Week 24)
  • Percent change in fasting concentrations of APOB(Baseline to Week 24)
  • Percent change in fasting concentrations of APOC3(Baseline to Week 12)
  • Absolute change in fasting concentrations of APOC3(Baseline to Week 12)
  • Absolute change in fasting concentrations of HDL-C(Baseline to Week 12)
  • Absolute change in fasting concentrations of LDL-C(Baseline to Week 12)
  • Absolute change in fasting concentrations of TG(Baseline to Week 12)
  • Percent change in fasting concentrations of non-HDL-C(Baseline to Week 12)
  • Absolute change in fasting concentrations of non-HDL-C(Baseline to Week 12)
  • Absolute change in fasting concentrations of APOB(Baseline to Week 12)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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