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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01105975
First received: April 15, 2010
Last updated: September 20, 2011
Last verified: July 2011

April 15, 2010
September 20, 2011
April 2010
June 2011   (final data collection date for primary outcome measure)
  • Percent change from baseline to 12 week endpoint in high density lipoprotein cholesterol (HDL-C) with LY2484595 in combination with atorvastatin and atorvastatin monotherapy [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 week endpoint in low density lipoprotein cholesterol (LDL-C) with LY2484595 in combination with atorvastatin and atorvastatin monotherapy [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01105975 on ClinicalTrials.gov Archive Site
  • Percent change from baseline to 12 weeks in HDL-C with LY2484595 and Placebo [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 weeks in LDL-C with LY2484595 and Placebo [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 week endpoint in HDL-C with LY2484595 in combination with simvastatin or rosuvastatin and simvastatin/rosuvastatin monotherapy [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline to 12 week endpoint in LDL-C with LY2484595 in combination with simvastatin or rosuvastatin and simvastatin/rosuvastatin monotherapy [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics - Area Under the Curve (AUC) [ Time Frame: 2, 4, 8, and 12 weeks and 4-6 weeks follow-up ] [ Designated as safety issue: No ]
  • Percent change in plasma Cholesteryl Ester Transfer Protein (CETP) activity [ Time Frame: Baseline, 4, 8, and 12 weeks and 4-6 weeks follow-up ] [ Designated as safety issue: No ]
  • Percent change in plasma Cholesteryl Ester Transfer Protein (CETP) mass [ Time Frame: Baseline, 4, 8 and 12 weeks and 4-6 weeks follow-up ] [ Designated as safety issue: No ]
  • Incidence and severity of rashes [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 week endpoint in blood pressure [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 week endpoint in serum aldosterone [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 week endpoint in plasma renin activity [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 week endpoint in plasma potassium [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 week endpoint in serum sodium [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 12 week endpoint in serum bicarbonate [ Time Frame: Baseline, 12 weeks ] [ Designated as safety issue: Yes ]
  • Change from baseline to 6 week follow-up in EuroQol-5 dimensions (EQ-5D) score [ Time Frame: Baseline, 6 week follow-up ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

Patients will be stratified according to baseline levels of serum triglycerides (<150 or greater than or equal to 150 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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Dyslipidemia
  • 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
  • Experimental: 30 mg LY2484595 monotherapy
    Interventions:
    • Drug: LY2484595
    • Drug: Placebo for Statins
  • Experimental: 100 mg LY2484595 monotherapy
    Interventions:
    • Drug: LY2484595
    • Drug: Placebo for Statins
  • Experimental: 500 mg LY2484595 monotherapy
    Interventions:
    • Drug: LY2484595
    • Drug: Placebo for Statins
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo for LY2484595
    • Drug: Placebo for Statins
  • Active Comparator: 20 mg Atorvastatin monotherapy
    Interventions:
    • Drug: Atorvastatin
    • Drug: Placebo for LY2484595
  • Experimental: 100 mg LY2484595 + 20 mg Atorvastatin
    Interventions:
    • Drug: LY2484595
    • Drug: Atorvastatin
  • Active Comparator: 40 mg Simvastatin monotherapy
    Interventions:
    • Drug: Simvastatin
    • Drug: Placebo for LY2484595
  • Experimental: 100 mg LY2484595 + 40 mg Simvastatin
    Interventions:
    • Drug: LY2484595
    • Drug: Simvastatin
  • Active Comparator: 10 mg Rosuvastatin monotherapy
    Interventions:
    • Drug: Rosuvastatin
    • Drug: Placebo for LY2484595
  • Experimental: 100 mg LY2484595 + 10 mg Rosuvastatin
    Interventions:
    • Drug: LY2484595
    • Drug: Rosuvastatin
Nicholls SJ, Brewer HB, Kastelein JJ, Krueger KA, Wang MD, Shao M, Hu B, McErlean E, Nissen SE. Effects of the CETP inhibitor evacetrapib administered as monotherapy or in combination with statins on HDL and LDL cholesterol: a randomized controlled trial. JAMA. 2011 Nov 16;306(19):2099-109. doi: 10.1001/jama.2011.1649.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
430
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

• Diagnosed with Low HDL-C or hypercholesterolemia, after diet lead-in/washout of lipid therapies

Exclusion Criteria:

  • History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well
  • Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (ECG) to be compatible with participation in the study
  • History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema)
  • Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors)
  • Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs
  • Not willing to follow the diet (low-fat) that the study physician will recommend
  • Have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study
  • Breastfeeding woman or are a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Denmark,   Germany,   Netherlands,   Poland,   United Kingdom
 
NCT01105975
12468, I1V-MC-EIAF
Yes
Eli Lilly and Company
Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP