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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

Brief 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.

Condition or disease Intervention/treatment Phase
Dyslipidemia Drug: LY2484595 Drug: Atorvastatin Drug: Simvastatin Drug: Rosuvastatin Drug: Placebo for LY2484595 Drug: Placebo for Statins Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 398 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : April 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 30 milligram (mg) LY2484595 monotherapy Drug: LY2484595
Administered daily by mouth for 12 weeks
Drug: Placebo for Statins
Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 monotherapy Drug: LY2484595
Administered daily by mouth for 12 weeks
Drug: Placebo for Statins
Administered daily by mouth for 12 weeks
Experimental: 500 mg LY2484595 monotherapy Drug: LY2484595
Administered daily by mouth for 12 weeks
Drug: Placebo for Statins
Administered daily by mouth for 12 weeks
Placebo Comparator: Placebo Drug: Placebo for LY2484595
Administered daily by mouth for 12 weeks
Drug: Placebo for Statins
Administered daily by mouth for 12 weeks
Active Comparator: 20 mg Atorvastatin monotherapy Drug: Atorvastatin
Administered daily by mouth for 12 weeks
Drug: Placebo for LY2484595
Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 + 20 mg Atorvastatin Drug: LY2484595
Administered daily by mouth for 12 weeks
Drug: Atorvastatin
Administered daily by mouth for 12 weeks
Active Comparator: 40 mg Simvastatin monotherapy Drug: Simvastatin
Administered daily by mouth for 12 weeks
Drug: Placebo for LY2484595
Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 + 40 mg Simvastatin Drug: LY2484595
Administered daily by mouth for 12 weeks
Drug: Simvastatin
Administered daily by mouth for 12 weeks
Active Comparator: 10 mg Rosuvastatin monotherapy Drug: Rosuvastatin
Administered daily by mouth for 12 weeks
Drug: Placebo for LY2484595
Administered daily by mouth for 12 weeks
Experimental: 100 mg LY2484595 + 10 mg Rosuvastatin Drug: LY2484595
Administered daily by mouth for 12 weeks
Drug: Rosuvastatin
Administered daily by mouth for 12 weeks



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State [ Time Frame: Baseline up to 12 weeks ]
  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105975


  Show 59 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01105975     History of Changes
Other Study ID Numbers: 12468
I1V-MC-EIAF ( Other Identifier: Eli Lilly and Company )
First Posted: April 19, 2010    Key Record Dates
Results First Posted: March 22, 2018
Last Update Posted: March 22, 2018
Last Verified: February 2018

Keywords provided by Eli Lilly and Company:
Dyslipidemias
Mixed dyslipidemia
Hypercholesterolemia
Atherosclerosis
Atorvastatin
Simvastatin
Rosuvastatin
Metabolic Diseases
Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Cholesteryl Ester Transfer Protein Inhibitors
Cholesteryl Ester
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Rosuvastatin Calcium
Simvastatin
Evacetrapib
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors