NCT01105975

A Study of LY2484595 in Patients With High LDL-C or Low HDL-C

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 398 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of your participation in this study is to help answer the following research question(s) * Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone. * Whether LY2484595 alone improves blood fats profile compared to sugar pills. * Whether LY2484595 interferes with break down or functioning of statins. * Whether LY2484595 has any side effects that would not support testing it in future studies.

Detailed description

Patients will be stratified according to baseline levels of serum triglycerides (\<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (\<45 or greater than or equal to 45 mg/dL for men; \<50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.

Conditions

• Dyslipidemia

Interventions

Type	Name	Description
DRUG	LY2484595	Administered daily by mouth for 12 weeks
DRUG	Atorvastatin	Administered daily by mouth for 12 weeks
DRUG	Simvastatin	Administered daily by mouth for 12 weeks
DRUG	Rosuvastatin	Administered daily by mouth for 12 weeks
DRUG	Placebo for LY2484595	Administered daily by mouth for 12 weeks
DRUG	Placebo for Statins	Administered daily by mouth for 12 weeks

Timeline

• Start date: 2010-04-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-04-19
• Last updated: 2018-03-22
• Results posted: 2018-03-22

Locations

59 sites across 6 countries: United States, Denmark, Germany, Netherlands, Poland, United Kingdom