Efficacy and Safety of LY2484595 Hypercholesterolemia or Low HDL-C

• Research type

  Research Study

• Full title

  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

• IRAS ID

  45495

• Contact name

  John Robinson

• Sponsor organisation

  Eli Lilly and Company

• Eudract number

  2009-017479-29

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is 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. Study EIAF is an outpatient, multicenter, randomized, double-blind, double-dummy, parallel group, placebo- and active-controlled, Phase 2, efficacy and safety study in approximately 400, patients with hypercholesterolemia or low HDL-C. Patients will be stratified according to baseline levels of serum triglycerides (<150 or =150 mg/dL) and HDL-C (<45 or =45 mg/dL for men; <50 or =50 mg/dL for women), and by region (US or Europe). Study I1V-MC-EIAF (EIAF) will determine whether patients with hypercholesterolemia or low HDL-C treated with LY2484595 administered as monotherapy and in combination with atorvastatin, simvastatin, or rosuvastatin for 12 weeks will demonstrate adequate increases in HDL-C and decreases in LDL-C. This will be the first study of LY2484595 in a patient population. Study EIAF will assess the safety and tolerability of LY2484595 in dyslipidemic patients. Efficacy and safety data from this Phase 2 study will be used to select an appropriate dose level for Phase 3.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/35

• Date of REC Opinion

  30 Jun 2010

• REC opinion

  Further Information Favourable Opinion