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

NCT05687071 | Completed Phase 3 Results

• 1 other identifier: 346-102-00003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Outcome Measures

Primary Outcomes (2)

• Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)

  From baseline to week 52

• Percent Change in Low-density Lipoprotein Cholesterol (LDL-C) From Baseline to Week 52

  Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100.

  Baseline, week52

Secondary Outcomes (6)

• Percent Change in Non-HDL Cholesterol From Baseline to Week 52

  Baseline, week52

• Percent Change in Total Cholesterol From Baseline to Week 52

  Baseline, week52

• Percent Change in Apolipoprotein B From Baseline to Week 52

  Baseline, week52

• Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 52

  Baseline, week52

• Percent Change in Hemoglobin A1c From Baseline to Week 52

  Baseline, week52

Study Arms (1)

ETC-1002 180mg

EXPERIMENTAL

Drug: 180mg of ETC-1002(bempedoic acid)

Interventions

180mg of ETC-1002(bempedoic acid) DRUG

180mg, tablet, once daily, for 52 weeks

ETC-1002 180mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<400 mg/dL at screening

You may not qualify if:

• Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
• Patients with homozygous familial hypercholesterolemia (HoFH)
• Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening
• Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening
• Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of \<10.0 g/dL at screening
• Patients with uncontrolled diabetes with HbA1c of ≥9% at screening
• Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Rinku General Medical Center

Izumisano, Japan

Location

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co., Ltd.

CL_OPCJ_RDA_Team@otsuka.jp

+81363617314

Study Officials

• Takehisa Matsumaru

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 17, 2023
• Study Start: February 27, 2023
• Primary Completion: October 5, 2024
• Study Completion: November 2, 2024
• Last Updated: February 20, 2026
• Results First Posted: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)