Phase 2
Completed N=63
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg, Ezetimibe 10mg, and Atorvastatin 20 mg Triplet Therapy in Patients With Elevated LDL-C
Source: ClinicalTrials.gov NCT03051100 ↗Enrolled (actual)
63
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6 — -3.1; -63.6 percent change — p=<0.001
Summary
The purpose of this study is to determine if triplet therapy with bempedoic acid (ETC-1002) 180mg, ezetimibe 10mg, and atorvastatin 20mg is effective and safe versus placebo in patients with elevated LDL cholesterol.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 6 |
-3.1; -63.6 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipid Profile Parameters at Week 6 |
-1.3; -60.0; -1.1; -47.1; 0.6; -53.5 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Week 6 |
-2.7; -47.7 | <0.001 sig |
| SECONDARY Number of Participants With LDL-C <70 mg/dL at Week 6 |
0; 37 | <0.001 sig |
| SECONDARY Number of Participants With LDL-C Reduction ≥50% From Baseline at Week 6 |
0; 39 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- Fasting LDL-cholesterol between 130 - 189 mg/dL at screening following washout of all LDL-C-lowering drugs and nutritional supplements
- Men and nonpregnant, nonlactating women
- Sufficiently stable and suitable to undergo washout of all LDL-C-lowering drugs and nutritional supplements for 12 weeks
Exclusion Criteria
- Fasting blood triglycerides greater than or equal to 400 mg/dL
- Body Mass Index (BMI) greater than 50 kg/m2
- History of clinically significant cardiovascular disease
- History of type 1 or type 2 diabetes
Data sourced from ClinicalTrials.gov (NCT03051100). 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. Informational only — not medical advice.