CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 96 enrolled
Drug / intervention
180mg of ETC-1002(bempedoic acid) +1 moredrug
Likely dose
ETC-1002 (bempedoic acid) 180 mg orally once daily for 12 weeksAI-extracted
Key inclusion· 3
  • ✓Inadequate response to statins: taking statins (±other lipid-modifying therapies) but cannot achieve LDL-C goals
  • ✓Statin intolerance: safety problems with statin use that resolved on discontinuation/dose reduction, unable to achieve LDL-C goals, on lowest/approved dose of statin and/or stable lipid-modifying therapy
  • ✓Fasting triglycerides <400 mg/dL at screening
Key exclusion· 11
  • ✕Homozygous familial hypercholesterolemia (HoFH)
  • ✕Cardiovascular disease within past 3 months or developed during screening/before baseline
  • ✕Uncontrolled hypertension: systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg at screening
  • ✕Uncontrolled diabetes with HbA1c ≥9% at screening

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05683340
NCT05683340Phase 3Completed
CompareCT.gov

A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Jan 13, 2023·Updated Mar 13, 2025

In Brief

A Phase 3 clinical trial evaluating 180mg of ETC-1002(bempedoic acid) and Placebo for Hyper-low-density Lipoprotein (LDL) Cholesterolemia. Completed, enrolled 96 participants across 1 site.

Detailed Summary

The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein cholesterol (LDL C).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHyper-low-density Lipoprotein (LDL) Cholesterolemia
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
2023202420252026
First PostedJan 13, 2023
Enrollment StartFeb 13, 2023
Primary CompletionFeb 20, 2024
Study CompletionMar 12, 2024
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 3.5 years ago

Interventions

180mg of ETC-1002(bempedoic acid)drug

180mg, tablet, once daily, for 12 weeks

Placebodrug

placebo, tablet, once daily, for 12 weeks