A confirmatory trial of ETC-1002 in patients with hyper-LDL cholesterolemia

JRCT ID: jRCT2031220562

Registered date:11/01/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hyper-low-density lipoprotein (LDL) cholesterolemia
• Date of first enrollment: 13/02/2023
• Target sample size: 96
• Study type: Interventional
• Intervention(s): One ETC-1002(180 mg) or placebo tablets will be administered orally once daily for 12 weeks.

Outcome(s)

• Primary Outcome: Percent change in LDL-C from baseline at Week 12

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1)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).
2)Patients with fasting TG levels of <400 mg/dL at screening

Exclude criteria

1)Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
2)Patients with homozygous familial hypercholesterolemia (HoFH)
3)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
4)Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of >=160 mmHg or diastolic blood pressure of >=100 mmHg at screening
5)Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screening
6)Patients with uncontrolled diabetes with HbA1c of >=9% at screening
7)Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 x ULN at screening
8)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 x ULN or total bilirubin of >=2 x ULN at screening
9)Patients with creatine kinase (CK) of >3 x ULN at screening
10)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

Related Information

• Primary Sponsor: Matsumaru Takehisa
• Secondary ID(s): NCT05683340