Phase 3
N=130
A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT05687071 ↗Enrolled (actual)
130
Serious AEs
6.2%
Results posted
Feb 2026
Primary outcome: Primary: Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) — 109 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 180mg of ETC-1002(bempedoic acid) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) |
109 | — |
| PRIMARY Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52 |
-21.55 | — |
| SECONDARY Percent Change in Non-HDL Cholesterol From Baseline to Week 52 |
-19.36 | — |
| SECONDARY Percent Change in Total Cholesterol From Baseline to Week 52 |
-16.10 | — |
| SECONDARY Percent Change in Apolipoprotein B From Baseline to Week 52 |
-17.00 | — |
| SECONDARY Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 52 |
-14.39 | — |
| SECONDARY Percent Change in Hemoglobin A1c From Baseline to Week 52 |
0.24 | — |
| SECONDARY Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52 |
80 | — |
Summary
A Multicenter, Open-label Study to assess the safety and efficacy of ETC-1002 at 180 mg administered for 52 weeks in patients with hyper-LDL cholesterolemia
Eligibility Criteria
Inclusion Criteria
- Patients with inadequate response to statins or who have difficulty in treatment with statins as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who are currently taking or have previously taken statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Difficulty in treatment with statins] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, or of those patients who have a history of statin administration and who are judged to have concerns of safety problems associated with the administration or dose increase of statins and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).
- Patients with fasting TG levels of 1.5 × ULN at screening
- Patients with liver disease or dysfunction, including:
- Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screening
- Patients with creatine kinase (CK) of >3 × ULN at screening
- Patients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73 m2 at screening
- Other protocol specific exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT05687071). 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.