Clinical trial NCT05683340: A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Official title: A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyper-low-density Lipoprotein (LDL) Cholesterolemia
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-01-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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 \<400 mg/dL at screening
* Other protocol specific inclusion criteria may apply

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 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
* Other protocol specific exclusion criteria may apply

Primary outcomes:
measure: Percent Change in LDL-C From Baseline to Week 12
timeFrame: Baseline, week12
Secondary outcomes:
measure: Percent Change in Non-HDL Cholesterol From Baseline to Week 12
timeFrame: Baseline, week12
measure: Percent Change in Total Cholesterol From Baseline to Week 12
timeFrame: Baseline, week12
measure: Percent Change in Apolipoprotein B From Baseline to Week 12
timeFrame: Baseline, week12
measure: Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12
timeFrame: Baseline, week12
measure: Percent Change in Hemoglobin A1c From Baseline to Week 12
timeFrame: Baseline, week12
measure: Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12
timeFrame: Baseline, week12
Other outcomes:
Locations:
city: Izumisano-shi
country: Japan
facility: Rinku General Medical Center
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Takehisa Matsumaru
role: STUDY_DIRECTOR
References: