Study designed to evaluate the safety and efficacy of AMG 145, in people with elevated LDL-C and not treated with any other lipid-lowering medications.To do this, AMG 145 will be compared with placebo and with ezetimibe.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

•Subject has provided informed consent
•Male or female = 18 to = 80 years of age at signing of informed consent
•NCEP ATP III Framingham risk score of 10% or less (see Appendix E of Protocol)
•Fasting LDL-C = 100 mg/dL (2.6 mmol/L) and < 190 mg/dL (4.9 mmol/L) by central laboratory at screening
•Fasting triglycerides = 400 mg/dL (4.5 mmol/L) by central laboratory at screening

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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

-History of coronary heart disease (CHD) or CHD risk-equivalent disease as per NCEP ATP III (see Appendix D of Protocol)
-NYHA II - IV heart failure
-Uncontrolled serious cardiac arrhythmia defined as recurrent and highly symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications, in the past 3 months prior to randomization
-Diabetes mellitus or fasting serum glucose at screening = 126 mg/dL (7.0 mmol/L) or HbA1c = 6.5%
-Uncontrolled hypertension defined as sitting systolic blood pressure (SBP) > 160 mmHg or diastolic BP (DBP) > 100 mmHg
-Subject has taken lipid-regulating drugs in the last 3 months prior to LDLC screening, such as: HMG CoA reductase inhibitors, psyllium preparations including Metamucil® (> 2 tbs. per day), fibrates and derivatives, cholesterol absorption inhibitors such as ezetimibe, bile-acid sequestering resins; red yeast rice, > 200 mg per day niacin, and > 300 mg per day omega-3 fatty acids (eg, docosahexaenoic acid [DHA] and eicosapentaenoic acid [EPA] combined). Subjects currently on lipid lowering therapy when study enrollment begins may not be screened or randomized at any time in the future
-Subject has taken a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to LDL-C screening, such as: anacetrapib, dalcetrapib or evacetrapib.
-Treatment in the last 3 months prior to LDL-C screening with any of the following drugs: systemic cyclosporine, systemic steroids (eg, IV, intramuscular [IM], or PO) (Note: hormone replacement therapy is permitted), vitamin A derivatives and retinol derivatives for the treatment of dermatologic conditions (eg, Accutane); (Note: vitamin A in a multivitamin preparation is permitted)
-Uncontrolled hypothyroidism or hyperthyroidism as defined by thyroid stimulating hormone (TSH) < 1.0 time the lower limit of normal (LLN) or > 1.5 times the ULN, respectively, at screening
-Moderate to severe renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 at screening
-Active liver disease or hepatic dysfunction, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the ULN as determined by central laboratory analysis at screening
-CK > 3 times the ULN at screening
-Known active infection or major hematologic, renal, metabolic,
gastrointestinal or endocrine dysfunction in the judgment of the investigator
-Diagnosis of deep vein thrombosis or pulmonary embolism within 3 months prior to randomization
-Unreliability as a study participant based on the investigator's (or designee’s) knowledge of the subject (eg, alcohol or other drug abuse, inability or unwillingness to adhere to the protocol, or psychosis)
-Currently enrolled in another investigational device or drug study, or less than 30 days since ending another investigational device or drug study(s), or receiving other investigational agent(s)
-Female subject who has either (1) not used at least 1 highly effective method of birth control for at least 1 month prior to screening or (2) is not willing to use such a method during treatment and for an additional 15 weeks after the end of treatment, unless the subject is sterilized or postmenopausal;
• menopause is defined as 12 months of spontaneous and continuous amenorrhea in a female = 55 years old or 12 months of spontaneous and continuous amenorrhea with a follicle-stimulating

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials