Hypercholesterolemia or Low HDL-C MedDRA version: 12.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia MedDRA version: 12.1 Level: LLT Classification code 10024915 Term: Low HDL
Conditions
Interventions
Product Name: LY2484595
Product Code: LY2484595
Pharmaceutical Form: Film-coated tablet
Other descriptive name: LY2484595
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration nu
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 contraceptive, 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The main secondary objectives are: •To demonstrate whether LY2484595 administered as monotherapy significantly increases mean HDL-C and decreases mean LDL-C compared to placebo. •To evaluate the additive PD effects of LY2484595 administered in combination with simvastatin or rosuvastatin on mean HDL-C and LDL-C. •To evaluate the PK of LY2484595 in the presence of atorvastatin, simvastatin, and rosuvastatin. •To evaluate the effect of LY2484595 on plasma CETP activity and mass in the presence of statins. •To evaluate the effect of LY2484595 on the PK/PD profile of atorvastatin, simvastatin, and rosuvastatin. For a complete list of secondary objectives please refer to the study protocol.;Primary end point(s): The co-primary outcome variables are percent change in HDL-C and percent change in LDL C from baseline (Visit 2) to Visits 4, 5, 6, or 7. ;Main Objective: The primary objective of this study is to determine whether LY2484595, administered in combination with atorvastatin for 12 weeks to patients with hypercholesterolemia or low HDL-C, will significantly increase mean HDL-C and decrease mean LDL-C from baseline to endpoint, compared to atorvastatin alone. | — |
Countries
Denmark, Germany, Netherlands, United Kingdom
Outcome results
None listed