EUCTR2013-000622-55-DK进行中（未招募）不适用
A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients with Primary Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 528
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] Men or women greater than or equal to 18 years of age and less than or equal to 80 years of age
- •[2] Diagnosed with primary hypercholesterolemia (HC) defined as LDL =100 mg/dL (2.6 mmol/L) and TG =450 mg/dL (5.1 mmol/L)
- •o A subset of patients (~ 20%) with an LDL-C =80 mg/dL to <100 mg/dL (=2.1 mmol/L to <2. 6 mmol/L) will also be allowed.
- •o Includes at least ~20% heterozygous familial hypercholesterolemia (HeFH) and polygenic (non-familial) HC patients.
- •[3] Are on a stable diet and stable daily dose of atorvastatin, simvastatin, rosuvastatin, pravastatin, lovastatin, fluvastatin, or pitavastatin for at least 6 weeks and further adjustments of statin dose are not deemed clinically indicated by the investigator, or up to ~20% of patients with history of statin intolerance (i.e. patients who cannot tolerate any dose of at least 1 statin) who are not on statin treatment for at least 6 weeks, with or without a stable dose of ezetimibe for at least 6 weeks.
- •[4] Male patients with partner of childbearing potential: agree to use barrier protection during sexual intercourse during the study and for 3 months following the administration of the last dose of investigational product.
- •[5] Female patients including:
- •Women not of child bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they have a cessation of menses for at least 1 year (or 6 to 12 months of spontaneous amenorrhea with follicle stimulating hormone >40 mIU/mL (>40 IU/L); not taking hormones or oral contraceptives within 1 year.
- •Women of child bearing potential who have a negative urine or serum pregnancy test, are not breast feeding, and agree to use a reliable method of birth control up to at least 3 months following the last dose of study drug, where reliable is defined as birth control that results in a low failure rate (i.e., <1% per year) when used consistently and correctly.
- •[6] Have given informed consent to participate in the study.
- •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 317
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 211
排除标准
- •[1] Have secondary HC or homozygous familial HC.
- •[2] Have had myocardial infarction (MI), unstable angina (UA), percutaneous coronary intervention, coronary artery bypass graft, stroke, or deep vein thrombosis/pulmonary embolism within 3 months of screening, or have planned cardiovascular surgery or percutaneous coronary intervention.
- •[3] Have symptoms consistent with moderate or severe heart failure or are receiving treatment for symptomatic congestive heart failure (CHF) or known left ventricular ejection fraction (LVEF) <30%.
- •[4] Uncontrolled hypertension characterized by a systolic blood pressure >160 mmHg or
- •diastolic blood pressure >100 mmHg.
- •[5] Have diabetes mellitus (type 1 or 2) that requires or is likely to require any injectable glucose lowering therapy (including insulins) during the course of the study or have
- •hemoglobin A1c (HbA1c) =8.5%.
- •[6] Have thyroid-stimulating hormone (TSH) levels outside normal reference range for the central laboratory. Patients who are clinically euthyroid and on stable thyroid replacement therapy for at least 2 months prior to screening and who are anticipated to remain on this dose throughout the trial period are acceptable exceptions to this criterion.
- •[7] Have a history of adrenal insufficiency, Cushing's syndrome, or other adrenal gland disorder.
- •[8] Have a history of vitamin E deficiency or fat malabsorption syndrome.
- •[9] Have a serum creatinine =176.8 µM/L, nephrotic syndrome, or end stage renal disease and use renal replacement therapy such as hemodialysis or peritoneal dialysis
- •[10] Have active hepatobiliary disease, serologic evidence of past or active hepatitis B or C, or past or active gallbladder disease.
- •[11] Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or total bilirubin >2X ULN.
- •[12] Have a history or presence of a chronic muscular or neuromuscular disease including prior rhabdomyolysis or drug-induced myopathy or an unexplained/documented elevation in creatine kinase (CK) >3X ULN.
- •[13]Have hemoglobin <10 g/dL (6.2 mmol/L) in women and <11 g/dL (6.83 mmol/L) in men.
- •[14] Have a history of allergy, hypersensitivity or intolerance to drug preparations containing LY3015014, other PCSK9 antibodies, other monoclonal antibodies or any components of the formulation.
- •[15] Have a history of human immunodeficiency virus infection (HIV) infection, positive human HIV antibodies or other immune deficiency disorder.
- •[16] Have planned or are likely to require major surgery requiring anesthesia or hospitalization during the course of the study.
- •[17] Have chronic alcohol or drug abuse or dependency.
- •[18] Are currently under suspicion of having any cancer or malignancy or have had a history of cancer in the past 2 years, with the exception of non-melanoma skin cancers, cervical cancer in situ, breast ductal carcinoma in situ or stage 1 prostate cancer.
- •[19] Have an active serious infection.
- •[20] Have a history or presence of cardiovascular, respiratory, endocrine, gastrointestinal, hematological, autoimmune, metabolic, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
- •[21] Have started or stopped taking a statin or ezetimibe medication, or changed statin dose regimen within 6 weeks of randomization.
- •[22] Are on a stati
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