A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination with Atorvastatin, Simvastatin, and Rosuvastatin in Patients with Hypercholesterolemia or Low HDL-C. - EIAF

Eli Lilly0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Eli Lilly
入组人数: 60

研究概览入排标准研究者记录与标识符相似试验

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

年龄范围: 18 至 99（—）

入选标准

•Male or female patients with hypercholesterolemia or low HDL-C who are 18 years of age or older and have given informed consent are eligible to participate in this study.;Other criteria for inclusion include:
•* Diagnosed with low HDL-C or hypercholesterolemia, after diet lead-in/washout of lipid therapies.;Low HDL lipid criteria:
•- HDL-C <45 mg/dL (1.16 mmol/L) (men) and <50 mg/dL (1.29 mmol/L) (women), and
•- LDL-C according to National Cholesterol Education Program Adult Treatment Panel III
•(NCEP ATP III) guidelines , as follows:
•- LDL-C <190 mg/dL (4.91 mmol/L) (0-1 risk factors)
•- LDL-C <160 mg/dL (4.14 mmol/L) (2+ risk factors: 10-year CHD risk of <10%)
•- LDL-C <130 mg/dL (3.36 mmol/L) (2+ risk factors: 10-year CHD risk of 10-20%)
•- LDL-C <100 mg/dL (2.59 mmol/L) (diabetics), and
•- Fasting TG <400 mg/dL (4.52 mmol/L)
•High LDL-C lipid criteria:
•- LDL-C according to NCEP ATP III guidelines;factors and determination of 10-year CHD risk), as follows:
•- LDL-C 100-190 mg/dL (2.59 mmol/L-4.91 mmol/L) (0-1 risk factors)
•- LDL-C 100-160 mg/dL (2.59 mmol/L-4.14 mmol/L) (2+ risk factors: 10-year CHD risk of <10%)
•- LDL-C 100-130 mg/dL (2.59 mmol/L-3.36 mmol/L) (2+ risk factors: 10-year CHD risk of 10-20%)
•- Any HDL-C, and
•- Fasting TG <400 mg/dL (4.52 mmol/L);Note: The MOO provides guidance regarding on-treatment lipid levels that would
•support entering Diet Lead-in/Washout Phase. Patients with diabetes may be eligible
•only based on low HDL-C criteria.
•* Male patients who agree to use a reliable method of birth control during the study (and for 2 weeks following the last dose of study drug).
•* 1) Women not of childbearing potential due to surgical sterilization (hysterectomy, bilateral oopherectomy, or tubal ligation) or menopause. Postmenopausal is defined as women age *45 with an intact uterus who have not taken hormones or oral contraceptives within the last year and who have had either cessation of menses for at least 1 year, or 6 to 12 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) >40 mIU/mL (40 IU/L) OR 2) Women of child bearing potential who have a negative urine or serum pregnancy test and agree to use a reliable method of birth control (for example, injectable or implantable contraceptives [for example,
•Norplant®]; contraceptive transdermal patch; a reliable barrier method of birth control; or intrauterine device) during the study and for 2 weeks following the last dose of study drug.

排除标准

•Main criteria for exclusion include:
•* Have recent history (within 1 month of screening) of any clinically significant rash, history of any clinically severe drug-related rash, history of a chronic skin disorder (such as psoriasis, eczema, or urticaria), history of significant skin hypersensitivities to household or cosmetic products, or allergens per the investigator, or presence of widespread tattoos or other skin condition that limits the assessment for rashes. Patients who develop any rash during the Diet Lead-in/Washout Phase cannot be randomized.
•* Have or have had any clinical manifestation of coronary heart disease (CHD), such as stable or unstable angina, acute coronary syndrome, myocardial infarction, or a coronary revascularization procedure, including stent placement, symptomatic carotid artery disease, peripheral arterial disease, or abdominal aortic aneurysm.
•* Have systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg as determined by the mean of 3 standardized measurements in the sitting position at Visit 3
•* Have documented hyperaldosteronism.
•* 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) <35%. The absence of LVEF measurement does not prohibit entry into this study.
•* Have one of the following abnormalities: QTc prolongation (Bazett*s corrected QTc interval [QTcB]) of >450 msec in male patients or >470 msec in female patients, or abnormally wide QRS complexes (resulting from bundle branch blocks, intraventricular conduction delays, or pacemakers) or atrial fibrillation on screening electrocardiogram (ECG), previous history of QTc prolongation with another medication that required discontinuation, congenital long QT syndrome, previous history of ventricular tachycardia or unexplained syncope.
•* Have active hepatobiliary disease, serologic evidence of past or active hepatitis B or C, or past or active gallbladder disease. Patients who have been diagnosed with Gilbert syndrome or had a cholecytectomy greater than 3 months prior to enrollment can be included.
•* Have aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), or total bilirubin >1.5 times the upper limit of normal (ULN).
•* 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) >3 times ULN.
•* Have a history of discontinuation from statin, change of statin, or a dose reduction of statin due to history of hypersensitivity, intolerance, or adverse effect. Have a history of increased hepatic enzymes associated with use of an HMG-CoA reductase inhibitor (statin).
•* Have hemoglobin A1c *8.0%; or use, plan to use, or are likely to require insulin during the course of the study. Diabetic patients on an antidiabetic agent with lipid modifying effects must be on a stable dose for at least 1 month prior to screening to be eligible for the study.
•* Have a serum creatinine *2 mg/dL (153 *mol/L), or nephrotic syndrome, end-stage renal disease and use renal replacement therapy such as hemodialysis or peritoneal dialysis.
•* Have hemoglobin <10 gm/dL (6.2 mmol/L) in women and <11 gm/dL (6.83 mmol/L) in men.
•* Have current uncontrolled active inflammatory condition or infection which in the

研究者

发起方

Eli Lilly

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