EUCTR2021-005065-40-DK进行中（未招募）1 期
Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROADWAY): A Placebo-Controlled, Double-Blind, Randomized Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With Underlying HeFH and/or Atherosclerotic Cardiovascular Disease (ASCVD) Who are Not Adequately Controlled by Their Lipid Modifying Therapies
ewAmsterdam Pharma B.V.0 个研究点目标入组 2,400 人开始时间: 2022年3月10日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Are willing and able to give written informed consent before initiation of any study-related procedures and willing to comply with all required study procedures;
- •2. Are male or female =18 years of age at Screening (Visit 1);
- •o 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;
- •o Females of childbearing potential must have a negative urine pregnancy test at Screening (Visit 1);
- •3. Have underlying HeFH and/or a history of ASCVD
- •4. 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;
- •-Ezetimibe for at least 8 weeks with or without maximally tolerated statin prior to Screening (Visit 1);
- •-Bempedoic acid for at least 8 weeks in combination with a maximally tolerated statin prior to Screening (Visit 1); and/or
- •-A proprotein convertase subtilisin/kexin type 9 (PCSK9)-targeted therapy alone or in combination with other lipid-modifying therapy for at least 4 stable doses prior to Screening (Visit 1)
- •Note: At least 70% of the participants enrolled into this study must be taking HISs. HISs include the following:
- •- Atorvastatin 40 and 80 mg; and
- •-Rosuvastatin 20 and 40 mg
- •5. Have a fasting serum LDL-C as follows:
- •o Have a fasting serum LDL-C =55 mg/dL (=1.4 mmol/L) to <100 mg/dL (<2.6 mmol/L) OR non-HDL-C =85mg/dL (=2.2 mmol/L) to <130
- •mg/dL (<3.4 mmol/L) with at least 1 of the following risk enhancers:
- •-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 (Visit 1) or within 6 months prior to Screening (Visit 1)
- •-Fasting TG >150 mg/dL (>1.7 mmol/L);
- •-Fasting Lp(a) >30 mg/dL (>70 nmol/L); and/or
- •-Fasting HDL-C <40 mg/dL (<1.0 mmol/L);
- •-Have a fasting serum LDL-C =100 mg/dL (=2.6 mmol/L) OR non-HDL-C =130 mg/dL (=3.4 mmol/L).;
- •6. Have fasting TG <500 mg/dL (<5.7 mmol/L) at Screening; and
- •7. Have an estimated glomerular filtration rate (eGFR) =30 mL/min/1.73m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening (Visit 1).
- •Other protocol-defined criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1920
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 480
排除标准
- •1.Have current or any previous history of New York Heart Association class III or IV HF or left ventricular ejection fraction <30%;
- •2.Have been hospitalized for HF within 5 years prior to Screening (Visit );
- •3.Have had any of the following clinical events within 3 months prior to Screening (Visit 1):
- •o Non-fatal MI;
- •o Non-fatal stroke;
- •o Non-elective coronary revascularization; and/or
- •o Hospitalization for unstable angina and/or chest pain;
- •4.Have uncontrolled severe hypertension, defined as either systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg prior to Randomization (Visit 2) taken as the average of triplicate measurements. One triplicate retest will be allowed during the same visit, at which point if the retest result is no longer exclusionary, the participant may be randomized;
- •5.Have a formal diagnosis of homozygous familial hypercholesterolemia;
- •6.Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations inalanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 x upper limit of normal (ULN); or total bilirubin >2 x ULN at Screening;
- •7.Have HbA1c =10% (=0.100 hemoglobin fraction) or a fasting glucose =270 mg/dL (=15.0 mmol/L) at Screening (Visit 1);
- •8.Have thyroid-stimulating hormone >1.5 x ULN at Screening (Visit 1);
- •9.Have creatine kinase >3 x ULN at Screening (Visit 1);
- •10.Have a history of a malignancy that required surgery (excluding local and wide local excision), radiation therapy, and/or systemic therapy during the 3 years prior to Randomization (Visit 2);
- •11.Have a known history of alcohol and/or drug abuse within 5 years prior to Randomization (Visit 2);
- •12.Have received treatment with other investigational products or devices within 30 days of Screening (Visit 1) or 5 half lives of the previous investigational product, whichever is longer;
- •13.Are taking gemfibrozil or have taken gemfibrozil within 30 days of Screening (Visit 1);
- •14.Have planned use of other investigational products or devices during the course of the study;
- •15.Have participated in any clinical study evaluating obicetrapib;
- •16.Have a known allergy or hypersensitivity to the study drug, placebo, or any of the excipients in the study drug or placebo; or
- •17.Have any participant condition that, according to the Investigator, could interfere with the conduct of the study, such as, but not limited to, the following:
- •o Are unable to communicate or to cooperate with the Investigator;
- •o Are unable to understand the protocol requirements, instructions and study-related restrictions, and the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency);
- •o Are unlikely to comply with the protocol requirements, instructions,and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study);
- •o Have any medical or surgical condition which, in the opinion of the Investigator, would put the participant at increased risk from participating in the study; or
- •o Are directly involved in the conduct of the study.
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