Clinical trial NCT05687071: A Long-term Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia
Official title: A Multicenter, Open-label, Uncontrolled, Long-term Trial to Assess the Safety and Efficacy 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: 2023-01-17
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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
* 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
* 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: Number of Subjects Experiencing Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From baseline to week 52
measure: Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 52
timeFrame: Baseline, week52
Secondary outcomes:
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: