Hypercholesterolemia MedDRA version: 9.1 Level: LLT Classification code 10020603 Term: Hypercholesterolaemia
Conditions
Interventions
Product Name: Eprotirome
Product Code: KB2115
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: eprotirome
Current Sponsor code: KB2115
Concentration unit: µg microgram(s)
Concentratio
Sponsors
Karo Bio AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent Males or females aged > 18 to 3.0 mmol/L at Enrolment and Visit Week –1. Patient able and willing to comply with all study requirements At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Cholesterol lowering agents other than ezetimibe History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator Chronic (> 3 months) pain condition requiring daily medication with pain killers Glycosylated hemoglobin (HbA1c) > 7.5% at week -1 Diabetes requiring medication other than metformin Cholestyramine, anticoagulants (eg. Warfarin) or cyclosporine (due to ezetimibe interactions). Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting electrocardiogram (ECG), eg, QTc interval > 500 msec at enrolment or week -1 Body Mass Index of = 40 kg/m2 Resent history ( 160/95 mm Hg at baseline History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia and atrial fibrillation Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or percutaneous coronary intervention 2 Unstable or severe angina pectoris or peripheral artery disease Known thyroid disease or thyroid biomarkers (thyroid-stimulating hormone [TSH], T3, free T3, T4, free T4) outside reference range for normal at enrolment and week -1 Positive urine pregnancy test in women at enrolment Use of thyroid replacement therapy and hormone replacement therapy (including contraceptive pills) for last 3 months before randomization Positive test for human immunodeficiency virus (HIV), hepatitis B or C at week -1 Known impairment of liver function or known liver disease, such as hepatitis or liver cirrhosis Bilirubin, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase or -glutamyl transpeptidase > 1.5-fold ULN at Enrollment (Screening Visit) or Visit Week 1 History of (past 2 years) or present alcohol or drug abuse as judged by the investigator or patients who consume > 14 alcoholic drinks per week. Involvement in the planning and conduct of the study (applies to both Karo Bio AB staff and clinical research organizations) Participation in a clinical study during the past 30 days anticipated to interfere with the objectives of the study as judged by the investigator Previous randomization of treatment in present study or previous treatment with KB2115
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of different doses of KB2115 as add on to ezetimibe treatment on low-density lipoprotein (LDL) cholesterol in patients with primary hypercholesterolemia;Secondary Objective: To assess safety and tolerability of different doses of KB2115 as add on to ezetimibe treatment in patients with primary hypercholesterolemia. To assess plasma concentration time relationship and exposure in terms of AUC and Cmax of KB2115, KB42899 and, possibly, related conversion products in a subset of 24 patients. To assess the influence of different doses of KB2115 as add on to ezetimibe treatment on blood lipids including cholesterol (total and high-density lipoprotein [HDL]), triglycerides, free fatty acids, apolipoprotein A-I, A-II, B and apolipoprotein B/apolipoprotein A-1 ratio and lipoprotein (a). If the results from the study requires, extra analyses regarding lipid metabolism may be performed. To assess the influence of add on with KB2115 on the pituitary-thyroid axis by determination of biomarkers of thyroid activity. ;Primary end point(s): The absolute change in LDL-cholesterol levels from baseline to week 10 will be used to evaluate the effects of multiple doses of KB2115 | — |
Countries
Sweden
Outcome results
None listed