EUCTR2021-005064-22-PL进行中（未招募）1 期
Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies (BROOKLYN): A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of 10 mg Obicetrapib in Participants With a History of HeFH and LDL-C =70 mg/dL Who are Not Adequately Controlled by Their Lipid-Modifying Therapies
ewAmsterdam Pharma B.V.0 个研究点目标入组 354 人开始时间: 2022年11月2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
- 354
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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 and =18 years of age at Screening;
- •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.
- •3. Have a history of HeFH as defined by at least 1 of the following:
- •o Genotyping by a central laboratory;
- •o Clinical assessment using the WHO Criteria/Dutch Lipid Clinical Network Criteria with a score of >8 points; and/or
- •o Meet the Simon Broome Register Diagnostic Criteria for definite or possible Familial Hypercholesterolemia (FH).
- •4. Are on maximally tolerated lipid-modifying therapy, as an adjunct to diet, defined as follows:
- •o A statin at a maximally tolerated stable dose;
- •o Ezetimibe for at least 8 weeks with or without maximally tolerated statin prior to Screening;
- •o Bempedoic acid for at least 8 weeks in combination with maximally tolerated statin prior to Screening;
- •o 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;
- •5. Have a fasting serum LDL-C =70 mg/dL (=1.81 mmol/L) at Screening;
- •6. Have fasting TG <400 mg/dL (<4.52 mmol/L) at Screening; and
- •7. Have an estimated glomerular filtration rate =30 mL/min/1.73 m2
- •calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at Screening.
- •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 241
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 113
排除标准
- •1. Have current or any previous history of New York Heart Association class III or IV heart failure (HF) or left ventricular ejection fraction <30%;
- •2. Have been hospitalized for HF within 5 years prior to Screening;
- •3. Have had any of the following clinical events within 3 months prior to Screening:
- •o Non-fatal myocardial infarction;
- •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 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 FH;
- •6. Have active liver disease, defined as any known current infectious, neoplastic, or metabolic pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate
- •aminotransferase (AST) >3 x upper limit of normal (ULN); or total bilirubin >2 x ULN at Screening;
- •7. Have glycosylated hemoglobin =10.0% (=0.100 hemoglobin fraction) or a fasting glucose =270 mg/dL (=15.0 mmol/L) at Screening;
- •8. Have thyroid-stimulating hormone >1.5 X ULN at Screening;
- •9. Have creatine kinase >3 x ULN at Screening;
- •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;
- •11. Have a known history of alcohol and/or drug abuse within 5 years prior to Randomization;
- •12. Have 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;
- •13.Are taking gemfibrozil;
- •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.
- •Other protocol-defined criteria apply.
研究者
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