NCT04832971已完成2 期
A Double-blind, Placebo-controlled Phase 2b Study to Evaluate the Efficacy and Safety of ARO-ANG3 in Adults With Mixed Dyslipidemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 24
- 主要终点
- Percent Change From Baseline in Fasting TG at Week 24
研究概览
简要总结
The purpose of AROANG3-2001 is to evaluate the efficacy and safety of ARO-ANG3 in participants with mixed dyslipidemia. Participants will initially receive 2 subcutaneous injections of ARO-ANG3 or placebo. Participants who complete the double-blind treatment period may opt to continue in an open-label extension during which they will receive up to 8 doses of ARO-ANG3.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Based on medical history, evidence of triglycerides (TG) ≥ 150 mg/dL but ≤ 499 mg/dL
- •Fasting levels at Screening of LDL-C ≥ 70 mg/dL OR non-HDL-C ≥ 100 mg/dL after at least 4 weeks of stable diet and stable optimal statin therapy
- •Mean fasting TG ≥ 150 mg/dL and ≤ 499 mg/dL during Screening collected at two separate and consecutive visits and at least 7 days apart and not more than 17 days apart
- •Willing to follow diet counseling and maintain a stable diet per Investigator judgment based on local standard of care
- •Participants of childbearing potential must agree to use highly-effective contraception during the study and for at least 24 weeks from last dose of study medication
- •Women of childbearing potential must have a negative pregnancy test and cannot be breastfeeding
- •Women of childbearing potential on hormonal contraceptives must be stable on the medication for ≥ 2 menstrual cycles prior to Day 1
- •Men must not donate sperm during the study and for at least 24 weeks following the last dose of study medication
- •Able and willing to provide written informed consent and to comply with study requirements
排除标准
- •Current use or use within 365 days from Day 1 of any hepatocyte targeted siRNA or antisense oligonucleotide molecule
- •Active pancreatitis within 12 weeks prior to Day 1
- •Any planned bariatric surgery or similar procedures to induce weight loss from consent to end of study
- •Acute coronary syndrome event within 24 weeks of Day 1
- •Major surgery within 12 weeks of Day 1 or planned surgery during the study
- •Planned coronary intervention (e.g., stent placement or heart bypass) during the study
- •Uncontrolled hypertension
- •Human immunodeficiency virus (HIV) infection, seropositive for Hepatitis B (HBV), seropositive for Hepatitis C (HCV)
- •Uncontrolled hypothyroidism or hyperthyroidism
- •Hemorrhagic stroke within 24 weeks of Day 1
- •History of bleeding diathesis or coagulopathy
- •Current diagnosis of nephrotic syndrome
- •Systemic use of corticosteroids or anabolic steroids within 4 weeks prior to Day 1 or planned use during the study
- •Malignancy within the last 2 years prior to date of consent requiring systemic treatment (some exceptions apply)
- •Note: additional inclusion/exclusion criteria may apply per protocol
研究组 & 干预措施
ARO-ANG3 50 mg
Experimental
Two doses of ARO-ANG3 by subcutaneous (sc) injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
干预措施: ARO-ANG3 (Drug)
ARO-ANG3 100 mg
Experimental
Two doses of ARO-ANG3 bysc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
干预措施: ARO-ANG3 (Drug)
ARO-ANG3 200 mg
Experimental
Two doses of ARO-ANG3 by sc injection at Day 1 and Week 12 during double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
干预措施: ARO-ANG3 (Drug)
Placebo
Placebo Comparator
Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
干预措施: ARO-ANG3 (Drug)
Placebo
Placebo Comparator
Calculated volume to match active treatment by sc injection at Day 1 and Week 12 during the double-blind treatment period. Up to 8 doses of ARO-ANG3 by sc injection during the open-label extension period.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Fasting TG at Week 24
时间窗: Baseline, Week 24
次要结局
- Percent Change From Baseline in Fasting TG Over Time(Baseline, up to Week 36 (double-blind treatment period))
- Percent Change From Baseline in Fasting Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) at Week 24(Baseline, Week 24)
- Percent Change From Baseline in Fasting Non-HDL-C Over Time(Baseline, up to Week 36 (double-blind treatment period))
- Percent Change From Baseline in Fasting Total Apolipoprotein B (ApoB) at Week 24(Baseline, Week 24)
- Percent Change From Baseline in Fasting Total ApoB Over Time(Baseline, up to Week 36 (double-blind treatment period))
- Percent Change From Baseline in Fasting Low-density Lipoprotein-Cholesterol (LDL-C) Using Ultracentrifugation at Week 24(Baseline, Week 24)
- Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time(Baseline, up to Week 36 (double-blind treatment period))
- Percent Change From Baseline in Angiopoietin-like Protein 3 (ANGPTL3) at Week 24(Baseline, Week 24)
- Percent Change From Baseline in ANGPTL3 Over Time(Baseline, up to Week 36 (double-blind treatment period))
- Percent Change From Baseline in Fasting High-Density Lipoprotein-Cholesterol (HDL-C) at Week 24(Baseline, Week 24)
- Percent Change From Baseline in Fasting HDL-C Over Time(Baseline, up to Week 36 (double-blind treatment period))
- Plasma Pharmacokinetic (PK) Concentration for ARO-ANG3 Over Time in the Double-Blind Treatment Period(Baseline, Day 1: pre-dose, 15 minutes, 1, 3, 6 hours post-dose; Day 2: 24 hours post-dose; Week 12: pre-dose, 15 minutes, 1, 3, 6, 24 hours post-dose (double-blind treatment period))
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and/or Serious TEAEs up to Week 24(From first dose of IP up to Week 24)
- Number of Participants With TEAEs and/or SAEs Over Time in the Double-Blind Treatment Period(up to Week 36 (double-blind treatment period))
- Number of Participants With AEs and/or SAEs Over Time in the Open-Label Extension (OLE) Period(From first dose of study drug in the OLE up to Month 24 (open-label extension))
- Percent Change From Baseline in Fasting TG Over Time in the Open Label Extension (OLE) Period(Baseline, OLE Baseline, Months 1-24 (open-label extension))
- Percent Change From Baseline in Fasting Non-HDL-C Over Time in the Open Label Extension (OLE) Period(Baseline, OLE Baseline, Months 1-24 (open-label extension))
- Percent Change From Baseline in Fasting Total ApoB Over Time in the Open Label Extension (OLE) Period(Baseline, OLE Baseline, Months 1-24 (open-label extension))
- Percent Change From Baseline in Fasting LDL-C Using Ultracentrifugation Over Time in the Open Label Extension (OLE) Period(Baseline, OLE Baseline, Months 1-24 (open-label extension))
- Percent Change From Baseline in ANGPTL3 Over Time in the Open Label Extension (OLE) Period(Baseline, OLE Baseline, Months 1-24 (open-label extension))
- Percent Change From Baseline in Fasting HDL-C Over Time in the Open Label Extension (OLE) Period(Baseline, OLE Baseline, Months 1-24 (open-label extension))
研究者
研究点 (24)
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