Hypercholesterolemia
Conditions
Keywords
Statin, LDL, Cholesterol
Brief summary
The purpose of this research study is to see how ETC-1002 is tolerated in the body and how ETC-1002 affects the levels of LDL-C (bad cholesterol) in patients receiving ongoing statin therapy.
Detailed description
Approximately 132 hypercholesterolemic patients already taking statin therapy to treat elevated LDL-C will be randomized in a ratio of 1:1:1 to receive either ETC-1002 (120 mg or 180 mg dose), or placebo for 12 weeks in addition to ongoing statin therapy. This study will explore the safety and efficacy of ETC-1002 when given to patients receiving statin therapy.
Interventions
DRUGETC-1002
ETC-1002 capsules, taken once daily oral
DRUGPlacebo
Placebo capsules, taken once daily oral
DRUGStatin Therapy
Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
Sponsors
Medpace, Inc.
Esperion Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Fasting, calculated mean LDL-C ≥130 mg/dL and ≤220 mg/dL * Fasting mean TG level ≤400 mg/dL * Stable statin therapy for at least 3 months prior to screening: atorvastatin (10 or 20 mg daily), simvastatin (5, 10 or 20 mg daily), rosuvastatin (5 or 10 mg daily), or pravastatin (10, 20 or 40 mg daily)
Exclusion criteria
* Clinically significant cardiovascular disease within 12 months of screening * Current muscle-related symptoms that may be due to ongoing statin therapy or a history of certain lab abnormalities that occurred during statin therapy and resolved when statin therapy was discontinued * Type 1 diabetes or uncontrolled type 2 diabetes * Use of metformin or thiazolidinediones (TZD) within 4 weeks of screening * History of chronic musculoskeletal symptoms such as fibromyalgia * Uncontrolled hypothyroidism * Liver disease or dysfunction * Renal dysfunction or nephritic syndrome * Gastrointestinal conditions or procedures or surgeries * Hematologic or coagulation disorders or low hemoglobin levels * HIV or AIDS * History of malignancy * History of drug or alcohol abuse within 2 years * Use of experimental or investigational drugs within 30 days of screening * Use of ETC-1002 in a previous clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in calculated low density lipoprotein-cholesterol (LDL-C) | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in non-high-density lipoprotein cholesterol (non-HDL-C) | 12 weeks |
| Percent change in apolipoprotein B (ApoB) | 12 weeks |
| Percent change in total cholesterol (TC) | 12 weeks |
| Percent change in high-sensitivity C-reactive protein (hsCRP) | 12 weeks |
| Percent change in triglycerides (TG) | 12 weeks |
| Percent change in lipoprotein particle number | 12 weeks |
| Safety using adverse event reports; clinical laboratory results | 12 weeks |
| Safety using adverse event reports; vital signs | 12 weeks |
| Pharmacokinetic plasma trough concentrations of ETC-1002 and metabolite 15228 | 12 weeks |
Countries
United States
Outcome results
None listed