Phase 2
N=398
A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT01105975 ↗Enrolled (actual)
398
Serious AEs
0.8%
Results posted
Mar 2018
Primary outcome: Primary: Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy — 1.4; 79.9 percent change of mg/dL — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LY2484595 (Drug); Atorvastatin (Drug); Simvastatin (Drug); Rosuvastatin (Drug); Placebo for LY2484595 (Drug); Placebo for Statins (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy |
1.4; 79.9 | <0.001 sig |
| PRIMARY Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy |
-33.6; -47.6 | 0.002 sig |
| SECONDARY Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo |
53.6; 94.6; 128.8; -3.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo |
-13.6; -22.3; -35.9; 3.9 | <0.001 sig |
| SECONDARY 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 |
7.3; 86.6; 5.5; 94.0 | <0.001 sig |
| SECONDARY 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 |
-34.9; -46.1; -38.8; -52.3 | 0.009 sig |
| SECONDARY Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State |
2300; 5900; 19700; 5500; 5620; 5960 | — |
| SECONDARY Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity |
-49.48; -70.80; -89.10; 12.12; -0.01; -72.00 | — |
| SECONDARY Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass |
63.94; 92.27; 136.66; 0.58; -11.8; 62.98 | — |
| SECONDARY The Number of Episodes of Rashes at Any Time From Baseline Through Week 12 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP) |
1.1; 0.8; 1.2; 1.6; 0.2; 1.2 | — |
| SECONDARY Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone |
-0.5; 1.0; -0.3; -1.0; -1.0; 0.4 | — |
| SECONDARY Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity |
-0.06; -0.11; -0.58; -0.30; -0.58; -0.26 | — |
| SECONDARY Change From Baseline to 12 Weeks Endpoint in Serum Potassium |
-0.04; 0.01; -0.02; -0.08; 0.09; 0.08 | — |
| SECONDARY Change From Baseline to 12 Weeks Endpoint in Serum Sodium |
0.3; 0.3; 0.5; 0.1; 1.3; 0.6 | — |
| SECONDARY Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate |
0.40; 0.60; 0.51; 0.27; 0.10; 0.58 | — |
| SECONDARY Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score |
0.008; 0.002; 0.012; -0.001; -0.002; -0.006 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01105975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.