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

NCT05683340 | Completed Phase 3 Results

• 1 other identifier: 346-102-00002
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent Change in LDL-C From Baseline to Week 12

  Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Day 1.

  Baseline, week12

Secondary Outcomes (6)

• Percent Change in Non-HDL Cholesterol From Baseline to Week 12

  Baseline, week12

• Percent Change in Total Cholesterol From Baseline to Week 12

  Baseline, week12

• Percent Change in Apolipoprotein B From Baseline to Week 12

  Baseline, week12

• Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12

  Baseline, week12

• Percent Change in Hemoglobin A1c From Baseline to Week 12

  Baseline, week12

Study Arms (2)

ETC-1002 180mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

180mg of ETC-1002(bempedoic acid) DRUG

180mg, tablet, once daily, for 12 weeks

ETC-1002 180mg

Placebo DRUG

placebo, tablet, once daily, for 12 weeks

Placebo

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 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 \<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 or before baseline visit
• 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

+81363617366

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 13, 2023
• Study Start: February 13, 2023
• Primary Completion: February 20, 2024
• Study Completion: March 12, 2024
• Last Updated: March 13, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-03

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)