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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ETC-1002 180mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 180mg of ETC-1002(bempedoic acid) | Drug | 180mg, tablet, once daily, for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Non-HDL Cholesterol 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 |
| Percent Change in Total Cholesterol From Baseline to Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Takehisa Matsumaru | Otsuka Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rinku General Medical Center | Izumisano | Japan |
Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ETC-1002 180 mg | ETC-1002 180 mg tablet once daily for 52 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ETC-1002 180 mg | ETC-1002 180 mg tablet once daily for 52 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs) | Safety Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period. | Posted | Count of Participants | Participants | From baseline to week 52 |
|
|
Adverse events were monitored from signing of the informed consent form until follow-up for up to 28 (+7) days after the last dose of study medication.
The safety analysis set will include subjects who receive at least one dose of IMP during the treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ETC-1002 180 mg | ETC-1002 180 mg tablet once daily for 52 weeks. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sudden hearing loss | Ear and labyrinth disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Otsuka Pharmaceutical Co., Ltd. | +81363617314 | CL_OPCJ_RDA_Team@otsuka.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2022 | Feb 2, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2024 | Feb 2, 2026 | SAP_001.pdf |
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Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. |
| Baseline, week52 |
| Percent Change in Apolipoprotein B 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 |
| Percent Change in High Sensitivity C Reactive Protein 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 |
| Percent Change in Hemoglobin A1c 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 |
| Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52 | The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 52. | Baseline, week52 |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
|
| Primary | 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. | Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter. | Posted | Mean | Standard Deviation | Percent Change | Baseline, week52 |
|
|
|
| Secondary | Percent Change in Non-HDL Cholesterol 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. | Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter. | Posted | Mean | Standard Deviation | Percent change | Baseline, week52 |
|
|
|
| Secondary | Percent Change in Total Cholesterol 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. | Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter. | Posted | Mean | Standard Deviation | Percent change | Baseline, week52 |
|
|
|
| Secondary | Percent Change in Apolipoprotein B 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. | Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter. | Posted | Mean | Standard Deviation | Percent change | Baseline, week52 |
|
|
|
| Secondary | Percent Change in High Sensitivity C Reactive Protein 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. | Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter. | Posted | Mean | Standard Deviation | Percent change | Baseline, week52 |
|
|
|
| Secondary | Percent Change in Hemoglobin A1c 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. | Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter. | Posted | Mean | Standard Deviation | Percent change | Baseline, week52 |
|
|
|
| Secondary | Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 52 | The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 52. | Efficacy Analysis Set consisted of subjects who received at least one dose of the IMP during the treatment period, and who have LDL-C measurements at baseline and at one or more time points after administration of the IMP during the treatment period. Efficacy sample consisted of all participants with both baseline and observation at each visit of the given parameter. | Posted | Count of Participants | Participants | Baseline, week52 |
|
|
|
| 130 |
| 8 |
| 130 |
| 73 |
| 130 |
| Cataract | Eye disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Eyelid ptosis | Eye disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Cholangitis | Hepatobiliary disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Cartilage neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Prostatitis | Reproductive system and breast disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Blood uric acid increased | Investigations | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA/J Ver.26.1 | Non-systematic Assessment |
|
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