NCT05142722已完成3 期
A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10mg Obicetrapib in Participants With HeFH and/or ASCVD Who Are Not Adequately Controlled by Their Lipid Modifying Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,530
- 试验地点
- 174
- 主要终点
- Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]
研究概览
简要总结
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying heterozygous familial hypercholesterolemia (HeFH) and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy
详细描述
This study will be a placebo-controlled, double-blind, randomized, phase 3 study in participants with underlying HeFH and/or ASCVD to evaluate the efficacy, safety, and tolerability of obicetrapib as an adjunct to diet and maximally tolerated lipid-lowering therapy. The screening period for this study will take up to 28 days. Afterwards patients will be randomized to placebo or 10 mg obicetrapib for a 365 day treatment period. After the treatment period, patients will have an end of study follow-up visit.
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)
盲法说明
placebo tablet made to resemble active
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
- •Females may be enrolled if all 3 of the following criteria are met:
- •They are not pregnant;
- •They are not breastfeeding; and
- •They do not plan on becoming pregnant during the study;
- •Have underlying heterozygous familial hypercholesterolemia (HeFH) and/or a history of established ASCVD
- •Are on maximally tolerated lipid-modifying therapy as an adjunct to a lipid-lowering diet and other lifestyle modifications, defined as follows:
- •A statin at a maximally tolerated stable dose for at least 8 weeks prior to Screening
- •Atorvastatin 40 and 80 mg; and
- •Rosuvastatin 20 and 40 mg;
- •Ezetimibe with or without maximally tolerated statin for at least 8 weeks prior to Screening
- •Bempedoic acid with a maximally tolerated statin for at least 8 weeks prior to Screening
- •A PCSK-9 targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening
- •Have a fasting serum LDL-C at Screening as follows:
- •Fasting serum LDL-C ≥ 55 to < 100 mg/dL (≥1.4 to <2.6 mmol/L) OR non-HDL-C ≥85 mg/dL (≥2.2 mmol/L) to < 130 mg/dL (<3.4 mmol/L) with at least 1 of the following risk enhancers at Screening;
- •Recent MI (> 3 and < 12 months prior to Randomization);
- •Type 2 diabetes mellitus;
- •Current daily cigarette smoking;
- •Age of > 60 years;
- •High sensitivity C-reactive protein (hsCRP) ≥2.0 mg/L (≥19.0 nmol/L) at Screening or within 6 months prior to Screening
- •Fasting triglycerides (TG) > 150 mg/dL (>1.7 mmol/L);
- •Fasting lipoprotein (a) > 30 mg/dL (>70 nmol/L); and/or
- •Fasting HDL-C < 40 mg/dL (<1.0 mmol/L); OR
- •Fasting serum LDL-C ≥ 100 mg/dL (≥2.6 mmol/L) or non-HDL-C ≥130 mg/dL (≥3.4 mmol/L)
- •Fasting triglyceride (TG) < 500 mg/dL (<5.7 mmol/L) at Screening; and
- •Have an estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73m2 at Screening
排除标准
- •New York Heart Association class III or IV heart failure or left ventricular ejection fraction < 30%;
- •Hospitalized for heart failure within 5 years prior to Screening
- •Major adverse cardiac event (MACE) within 3 months prior to Screening;
- •Uncontrolled severe hypertension, defined as either systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg prior to Randomization;
- •Formal diagnosis of homozygous familial hypercholesterolemia (HoFH);
- •Active liver disease;
- •HbA1c ≥10% or a fasting glucose ≥270 mg/dL (≥15.0 mmol/L) at Screening;
- •Thyroid-stimulating hormone >1.5 X upper limit of normal (ULN) at Screening;
- •Creatine kinase > 3 X upper limit of normal (ULN) at Screening;
- •History of malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization;
- •Known history of alcohol and/or drug abuse within 5 years prior to Randomization
- •Received treatment with other investigational products or devices within 30 days of Screening or 5 half-lives of the previous investigational product, whichever is longer;
- •Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening
- •Planned use of other investigational products or devices during the course of the study;
- •Participated in any clinical trial evaluating obicetrapib; or
- •Known allergy or hypersensitivity to obicetrapib, placebo, or any of the excipients in obicetrapib or placebo
- •Any condition that, according to the Investigator, could interfere with the conduct of the study
研究组 & 干预措施
Placebo
Placebo Comparator
one placebo tablet once daily
干预措施: Placebo (Drug)
obicetrapib 10mg
Experimental
one 10mg obicetrapib tablet once daily
干预措施: Obicetrapib (Drug)
结局指标
主要结局
Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) From Baseline to Day 84 [PUC]
时间窗: 84 Days
LS mean percent change from baseline to Day 84 in Low-Density Lipoprotein Cholesterol (LDL-C) in the obicetrapib group compared to the placebo group \[PUC\]. LDL-C level was measured by preparative ultracentrifugation (PUC).
次要结局
- Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 180 [Martin/Hopkins](180 Days)
- Percent Change in Low Density Lipoprotein-Cholesterol (LDL-C) From Baseline to Day 365 [PUC](365 Days)
- Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 84(84 Days)
- Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 180(180 Days)
- Percent Change in Apolipoprotein B (ApoB) From Baseline to Day 365(365 Days)
- Percent Change in Non-HDL-C From Baseline to Day 84(84 Days)
- Percent Change in Non-HDL-C From Baseline to Day 180(180 Days)
- Percent Change in Non-HDL-C From Baseline to Day 365(365 Days)
- Percent Change in HDL-C From Baseline to Day 84(84 Days)
- Percent Change in HDL-C From Baseline to Day 180(180 Days)
- Percent Change in HDL-C From Baseline to Day 365(365 Days)
- Percent Change in Lp(a) From Baseline to Day 84(84 Days)
- Percent Change in Apolipoprotein A1 (ApoA1) From Baseline to Day 84(84 Days)
- Percent Change in Total Cholesterol From Baseline to Day 84(84 Days)
- Percent Change in Total Cholesterol From Baseline to Day 180(180 Days)
- Percent Change in Total Cholesterol From Baseline to Day 365(365 Days)
- Percent Change in Triglycerides From Baseline to Day 84(84 Days)
- Percent Change in Triglycerides From Baseline to Day 180(180 Days)
- Percent Change in Triglycerides From Baseline to Day 365(365 days)
研究者
研究点 (174)
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