Phase 2
Completed N=59
Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy
Source: ClinicalTrials.gov NCT03193047 ↗Enrolled (actual)
59
Serious AEs
1.7%
Results posted
Apr 2020
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2 — 2.783; -27.478 percent change — p=<0.001
Summary
The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe 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 Month 2 |
2.783; -27.478 | <0.001 sig |
| SECONDARY Percent Change From Baseline in LDL-C at Month 1 |
3.172; -32.712 | <0.001 sig |
| SECONDARY Absolute Change From Baseline in LDL-C at Month 1 and Month 2 |
1.75; -36.51; -0.02; -29.92 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lipid Profile Parameters at Month 1 and Month 2 |
0.547; -26.484; 2.077; -29.563; 1.170; -20.770 | <0.001 sig |
| SECONDARY Percent Change From Baseline in High-sensitivity C-reactive Protein (Hs-CRP) at Month 1 and Month 2 |
10.658; -23.349; -1.623; -34.444 | 0.046 sig |
| SECONDARY Number of Participants With Any Treatment-emergent Adverse Event (AE) and Treatment-emergent Serious Adverse Event (SAE) |
7; 9; 1; 1; 1; 0 | — |
| SECONDARY Number of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) >3x the Upper Limit of Normal (ULN) at Month 1 and Month 2 |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Age ≥18 years or legal age of majority depending on regional law
- Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL
- Men and nonpregnant, nonlactating women
Exclusion Criteria
- Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia
- Total fasting TG ≥500 mg/dL
- Renal dysfunction or a glomerulonephropathy; eGFR 3 × ULN
- Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib
- Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment
Data sourced from ClinicalTrials.gov (NCT03193047). 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.