Health Condition 1: null- Heterozygous Familial Hypercholesterolemia
Conditions
Interventions
Intervention1: Eprotirome: eprotirome 50 micrograms each day for 100 weeks
eprotirome 50 micrograms each day for 14 days followed by eprotirome 100 micrograms daily for 98 weeks
Control Intervention
Sponsors
Karo Bio AB
Eligibility
Inclusion criteria
Inclusion criteria: •Patients with confirmed HeFH and 18 years of age at screening •Presence of clinical atherosclerotic disease that confers high risk for CAD events together with an LDL-C more than 2 mmol/L (more than 80 mg/dL) •Presence of risk factors for CVD (other than the HeFH diagnosis) together with an LDL-C more than 2.5 mmol/L (more than 100 mg/dL) •On an optimal standard of care, defined as being on a stable dose of statin (rosuvastatin, atorvastatin, or simvastatin) with or without ezetimibe for 8 weeks prior to randomisation
Exclusion criteria
Exclusion criteria: •Significant health problems in recent past including heart failure,cardiac electrophysiologic instability, rheumatoid arthritis, thyroid dysfunction, liver disease, cancer, secondary dyslipidaemia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent reduction in low-density lipoprotein cholesterol (LDL-C)Timepoint: From baseline to Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ Patients will be evaluated for knee-joint function and symptoms using a Patient Reported Outcome (PRO) questionnaire (Knee injury and Osteoarthritis Outcome Score [KOOS])Timepoint: -;â?¢ To assess the cardiovascular safety of eprotirome in a subset of patients using echocardiography and Holter monitoring to evaluate cardiac structure and functionTimepoint: -;â?¢ To assess the effects of eprotirome on skeleton by bone mineral density (BMD) using dual emission x-ray absorptiometry (DXA) scans of the lumbar spine in a subset of patientsTimepoint: -;â?¢ To compare the efficacy of eprotirome 50 mcg and eprotirome 100 mcg versus placebo in terms of the percent change in triglycerides (TG), high-density lipoprotein cholesterol (HDL C), non-HDL-C, total cholesterol (TC), apolipoprotein (apo) A-I, apo B, lipoprotein (a) (Lp[a]), and markers for inflammation (eg, high-sensitivity C-reactive protein [hsCRP])Timepoint: baseline to Week 12, Week 28, Week 52, Week 76, and Week 100;â?¢ To compare the efficacy of eprotirome 50 mcg and eprotirome 100 mcg versus placebo in terms of the proportion of patients who have a reduction in LDL-C of 15%Timepoint: baseline to Week 12;â?¢ To monitor the systemic exposure to the nitrated reaction product KB42899 in the population through sparse sampling and explore the pharmacokinetics (PK) of KB42899 and eprotirome through rich sampling in selected casesTimepoint: -;To assess the long-term safety and tolerability of eprotiromeTimepoint: -;To compare the efficacy of eprotirome 50 mcg and eprotirome 100 mcg versus placebo in terms of the percent change in LDL-CTimepoint: baseline to Week 28, Week 52, Week 76, and Week 100 | — |
Countries
Austria, Czech Republic, Denmark, India, Israel, Netherlands, Norway, Russian Federation, South Africa, Spain, Sweden, United Kingdom
Contacts
Public ContactSantosh Jamboti
Medpace Clinical Research India Pvt. Ltd.
Outcome results
None listed