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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 400

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] Diagnosed with low HDL-C or hypercholesterolemia, after diet lead-in/washout of lipid therapies
• Low HDL lipid criteria:
o HDL-C <45 mg/dL (1.16 mmol/L) (men) and <50 mg/dL (1.29 mmol/L) (women), and
o LDL-C according to National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) guidelines (see MOO for risk factors and determination of 10-year CHD risk), 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
o Fasting TG <400 mg/dL (4.52 mmol/L)
OR
• High LDL-C lipid criteria:
o LDL-C according to NCEP ATP III guidelines (see MOO for risk 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%)
o Any HDL-C, and
o Fasting TG <400 mg/dL (4.52 mmol/L)
Note: 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.
[2a] Male patients:Agree to use a reliable method of birth control during the study (and for 2 weeks following the last dose of study drug). See Manual of Operations for additional information regarding reliable methods of birth control.
[2b] Female patients:
1)Women not of childbearing potential due to surgical sterilization (hysterectomy, bilateral oopherectomy, or tubal ligation) or menopause. Postmenopausal is defined as women age > or = to 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).
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, oral contraceptives, 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. See Manual of Operations for additional information regarding reliable methods of birth control.
[3] Men and women equal or more than 18 years of age.
[4] 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

General Exclusion Criteria
[5] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[6] Are Eli Lilly and Company (Lilly) employees.
[7] Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device (other than the study drug used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
[8] Have completed or withdrawn from this study or have completed or withdrawn from any other study investigating LY2484595.
[9] Are unable, unreliable, and/or unwilling to provide informed consent, make themselves available for the duration of the study, or will not abide by the procedures and study restrictions (including those related to dietary guidelines; see MOO and Section 7.1).

Medical Conditions Exclusion Criteria and Prior/Concomitant Therapy Exclusion Criteria are defined in the study protocol.

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

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