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

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ClinicalTrials.gov Identifier: NCT01105975
Recruitment Status : Completed
First Posted : April 19, 2010
Results First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

April 15, 2010
April 19, 2010
February 18, 2018
March 22, 2018
March 22, 2018
April 2010
June 2011   (Final data collection date for primary outcome measure)
  • Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy [ Time Frame: Baseline, 12 weeks ]
  • Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy [ Time Frame: Baseline, 12 weeks ]
Complete list of historical versions of study NCT01105975 on ClinicalTrials.gov Archive Site
  • Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State [ Time Frame: Baseline up to 12 weeks ]
  • Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • The Number of Episodes of Rashes at Any Time From Baseline Through Week 12 [ Time Frame: Baseline through Week 12 ]
    All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.
  • Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP) [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Change From Baseline to 12 Weeks Endpoint in Serum Potassium [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Change From Baseline to 12 Weeks Endpoint in Serum Sodium [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate [ Time Frame: Baseline, Week 12 ]
    Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score [ Time Frame: Baseline up to Week 18 ]
    EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
  • Percent change from baseline to 12 weeks in HDL-C with LY2484595 and Placebo [ Time Frame: Baseline, 12 weeks ]
  • Percent change from baseline to 12 weeks in LDL-C with LY2484595 and Placebo [ Time Frame: Baseline, 12 weeks ]
  • 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 ]
  • 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 ]
  • Pharmacokinetics - Area Under the Curve (AUC) [ Time Frame: 2, 4, 8, and 12 weeks and 4-6 weeks follow-up ]
  • Percent change in plasma Cholesteryl Ester Transfer Protein (CETP) activity [ Time Frame: Baseline, 4, 8, and 12 weeks and 4-6 weeks follow-up ]
  • Percent change in plasma Cholesteryl Ester Transfer Protein (CETP) mass [ Time Frame: Baseline, 4, 8 and 12 weeks and 4-6 weeks follow-up ]
  • Incidence and severity of rashes [ Time Frame: 12 weeks ]
  • Change from baseline to 12 week endpoint in blood pressure [ Time Frame: Baseline, 12 weeks ]
  • Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone [ Time Frame: Baseline, 12 weeks ]
  • Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity [ Time Frame: Baseline, 12 weeks ]
  • Change from baseline to 12 week endpoint in plasma potassium [ Time Frame: Baseline, 12 weeks ]
  • Change From Baseline to 12 Weeks Endpoint in Serum Sodium [ Time Frame: Baseline, 12 weeks ]
  • Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate [ Time Frame: Baseline, 12 weeks ]
  • Change from baseline to 6 week follow-up in EuroQol-5 dimensions (EQ-5D) score [ Time Frame: Baseline, 6 week follow-up ]
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 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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 milligram (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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
398
400
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

• Diagnosed with Low High Density Lipoprotein Cholesterol (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 (Electrocardiogram [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 a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Germany,   Netherlands,   Poland,   United Kingdom,   United States
 
 
NCT01105975
12468
I1V-MC-EIAF ( Other Identifier: Eli Lilly and Company )
Yes
Not Provided
Not Provided
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
February 2018

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