Phase 2
Completed N=188
A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia
Source: ClinicalTrials.gov NCT04784442 ↗Enrolled (actual)
188
Serious AEs
1.1%
Results posted
Mar 2024
Primary outcomePrimary: Percent Change in LDL-C From Baseline to Week 12 — -10.59; -21.85; -21.26; -1.92 Percent Change — p=<0.001
Summary
The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in Japanese patients with hypercholesterolemia treated for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in LDL-C From Baseline to Week 12 |
-10.59; -21.85; -21.26; -1.92 | <0.001 sig |
| SECONDARY Percent Change in HDL Cholesterol From Baseline to Week 12 |
0.16; -0.65; -7.29; 3.08 | — |
| SECONDARY Percent Change in Non-HDL Cholesterol From Baseline to Week 12 |
-8.86; -18.29; -16.01; -1.62 | — |
| SECONDARY Percent Change in Total Cholesterol From Baseline to Week 12 |
-6.42; -13.61; -13.56; -0.55 | — |
| SECONDARY Percent Change in Triglycerides From Baseline to Week 12 |
-9.09; -5.62; 9.17; -0.08 | — |
| SECONDARY Percent Change in Apolipoprotein B From Baseline to Week 12 |
-8.18; -14.59; -12.47; -2.13 | — |
| SECONDARY Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12 |
150.54; 1.02; -34.58; 0.98 | — |
| SECONDARY Percent Change in Hemoglobin A1c From Baseline to Week 12 |
0.11; -0.40; -0.21; -0.05 | — |
| SECONDARY Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12 |
15; 26; 28; 1 | — |
| SECONDARY Proportion of Subjects Whose LDL-C Value Achieve < 70 mg/dL at Week 12 |
0; 1; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who have obtained informed consent to all of the observation/examination/evaluation items specified in the protocol
- Patients must be on stable statin therapy defined as atorvastatin, pitavastatin, rosuvastatin, pravastatin, simvastatin, or fluvastatin daily[and other lipid-modifying therapies(LMTs) if needed] at least 4 weeks(6 weeks for fibrates) prior to screening and above LDL-C control target. Or Patients for statin intolerant must be on stable LMT(s) at least 4 weeks prior to screening and above LDL-C control target. Statin intolerance defined as an inability to tolerate 1 or more statins due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued or decreased. Patients on the lowest or under the dosage of the approved dose of statin or unable to tolerate any statin at any dose were eligible. Patients could continue taking the lowest or under the dosage of the approved dose of statin therapy or taking other LMTs throughout the study provided that it was stable and well tolerated.
- Fasting mean TG level 1.5 × ULN at screening
- Patients with liver disease or dysfunction, including:
- Positive serology for hepatitis B surface antigen (HBsAg) and/or hepatitis C antibodies at screening
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN and/or total bilirubin of ≥2 × ULN
- Patients with creatine kinase (CK) elevation( >3 × ULN) at screening
- Patients with renal dysfunction or nephritic syndrome or a history of nephritis and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m2 at screening
- Other protocol specific inclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04784442). 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.