A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia

NCT04784442 | Completed Phase 2 Results

• 2 other identifiers: 346-102-00001jRCT2031200445
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in Japanese patients with hypercholesterolemia treated for 12 weeks.

Conditions

Hypercholesterolemia

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. When LDL-C at Week 12 was missing, the missing value was imputed using the last observation carried forward from the start of the IMP administration to 2 days after the final IMP administration.

  Baseline, week12

Secondary Outcomes (9)

• Percent Change in HDL Cholesterol From Baseline to Week 12

  Baseline, week12

• 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 Triglycerides From Baseline to Week 12

  Baseline, week12

• Percent Change in Apolipoprotein B From Baseline to Week 12

  Baseline, week12

Study Arms (4)

ETC-1002 180mg

EXPERIMENTAL

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

ETC-1002 120mg

EXPERIMENTAL

Drug: 120mg of ETC-1002(bempedoic acid)

ETC-1002 60mg

EXPERIMENTAL

Drug: 60mg 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

120mg of ETC-1002(bempedoic acid) DRUG

120mg, tablet, once daily, for 12 weeks

ETC-1002 120mg

60mg of ETC-1002(bempedoic acid) DRUG

60mg, tablet, once daily, for 12 weeks

ETC-1002 60mg

Placebo DRUG

placebo, tablet, once daily, for 12 weeks

Placebo

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have obtained informed consent to all of the observation/examination/evaluation items specified in the protocol
• Patients must be on stable statin therapy defined as atorvastatin, pitavastatin, rosuvastatin, pravastatin, simvastatin, or fluvastatin daily\[and other lipid-modifying therapies(LMTs) if needed\] at least 4 weeks(6 weeks for fibrates) prior to screening and above LDL-C control target. Or Patients for statin intolerant must be on stable LMT(s) at least 4 weeks prior to screening and above LDL-C control target. Statin intolerance defined as an inability to tolerate 1 or more statins due to an adverse safety effect that started or increased during statin therapy and resolved or improved when statin therapy was discontinued or decreased. Patients on the lowest or under the dosage of the approved dose of statin or unable to tolerate any statin at any dose were eligible. Patients could continue taking the lowest or under the dosage of the approved dose of statin therapy or taking other LMTs throughout the study provided that it was stable and well tolerated.
• Fasting mean TG level \< 400 mg/dL from measurements at screening

You may not qualify if:

• Women who are pregnant or breastfeeding or who have a positive pregnancy test (urine) result at screening or baseline visits
• Sexually active male subjects or sexually active female subjects of childbearing potential who do not agree to practice 2 different methods of birth control or to remain abstinent during the trial and for 30 days after final IMP administration test (urine) result at screening or baseline visits
• Patients with homozygous familial hypercholesterolemia (HoFH)
• Patients with a history or current symptoms of any of the following clinically significant cardiovascular diseases within 3 months prior to screening or before baseline visit
• Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, or decompensated heart failure
• Abdominal aortic aneurysm
• Unexplained syncope or long-QT syndrome, family history of long-QT syndrome, or risk factors for Torsade de Pointes, such as persistent hypokalemia or second- or third-degree atrioventricular block (except when controlled by medication, etc)
• Uncontrolled hypertension, defined as follows:
• 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 Hgb of \<10.0 g/dL at screening
• Patients with type 1 diabetes or uncontrolled type 2 diabetes with hemoglobin A1c (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) and/or hepatitis C antibodies at screening
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN and/or total bilirubin of ≥2 × ULN

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Tokyo-Eki Center-Building Clinic

Chuo-ku,Tokyo, Japan

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

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 2
• 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: March 2, 2021
• First Posted: March 5, 2021
• Study Start: March 24, 2021
• Primary Completion: April 18, 2022
• Study Completion: May 17, 2022
• Last Updated: May 10, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-05

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)