A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
- Registration Number
- NCT02659397
- Lead Sponsor
- Esperion Therapeutics, Inc.
- Brief Summary
The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- Taking daily stable statin doses for at least 4 weeks prior to screening visit.
- LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or,
- LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit.
- Must be willing to discontinue other lipid-regulating therapies during the study
- History of acute significant cardiovascular disease.
- Current clinically significant cardiovascular disease.
- History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ETC-1002 + Atorvastatin ETC-1002 ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily Placebo + Atorvastatin Placebo Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily ETC-1002 + Atorvastatin Atorvastatin ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily Placebo + Atorvastatin Atorvastatin Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
- Primary Outcome Measures
Name Time Method Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites 2 weeks Fold change in Cmax from prior-to to following 2 week treatment with ETC-1002
24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites 2 weeks Fold change in AUC from prior-to to following 2 week treatment with ETC-1002
Percent change in LDL-cholesterol 4 weeks Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C
- Secondary Outcome Measures
Name Time Method Percent change in hsCRP 4 weeks Percent change from baseline to following 4 week treatment with ETC-1002
Percent change in total cholesterol 4 weeks Percent change from baseline to following 4 week treatment with ETC-1002
Percent change in non-HDL-cholesterol 4 weeks Percent change from baseline to following 4 week treatment with ETC-1002
Percent change in apolipoprotein B 4 weeks Percent change from baseline to following 4 week treatment with ETC-1002
24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite 2 weeks Fold change in trough exposure from prior-to to following 2 week treatment with ETC-1002