Phase 3 N=96 Randomized Quadruple-blind Treatment

A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Bottom Line

View on ClinicalTrials.gov: NCT05683340 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2025

Primary outcome: Primary: Percent Change in LDL-C From Baseline to Week 12 — -25.25; -3.46 Percent Change — p=0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 180mg of ETC-1002(bempedoic acid) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Primary completion: Feb 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in LDL-C From Baseline to Week 12	-25.25; -3.46	0.001 sig
SECONDARY Percent Change in Non-HDL Cholesterol From Baseline to Week 12	-20.33; -2.76	—
SECONDARY Percent Change in Total Cholesterol From Baseline to Week 12	-16.36; -2.23	—
SECONDARY Percent Change in Apolipoprotein B From Baseline to Week 12	-18.10; -0.67	—
SECONDARY Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12	15.40; 119.60	—
SECONDARY Percent Change in Hemoglobin A1c From Baseline to Week 12	-0.87; 0.16	—
SECONDARY Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12	30; 4	—

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).

Eligibility Criteria

Inclusion Criteria

Patients with inadequate response to statins or statin intolerance as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who have been taking statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Statin intolerance] 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, 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05683340). 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.