Hypercholesterolemia
Conditions
Keywords
Eprotirome, KB2115, dyslipidemia, hypercholesterolemia, hypertriglyceridemia
Brief summary
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in clinical trials demonstrated pronounced reduction of several independent risk factors for the development of atherosclerotic cardiovascular diseases. The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a clinically relevant dose or dose range for future studies.
Interventions
DRUGEzetimibe and placebo
Placebo or three different doses of eprotirome added to ezetimibe treatment
DRUGEprotirome and ezetimibe
Placebo or three different doses of eprotirome added to ezetimibe treatment
Sponsors
Karo Bio AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Males or females aged 18 to 75 years * Patient with primary hypercholesterolemia with an LDL-cholesterol \> 3.0 mmol/L * 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
Exclusion criteria
* History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LDL cholesterol | 10 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides | 10 weeks |
Countries
Sweden
Outcome results
None listed