Hyperlipidemia
Conditions
Keywords
LDL-cholesterol, Hypercholesterolemia, ETC-1002, Adenosine triphosphate citrate lyase, Atorvastatin
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.
Interventions
DRUGETC-1002
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
DRUGAtorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
DRUGPlacebo
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
Sponsors
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 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percent change in apolipoprotein B | 4 weeks | Percent change from baseline to following 4 week treatment with ETC-1002 |
| Percent change in hsCRP | 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 |
| 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 |
Countries
United States
Outcome results
None listed