LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
Phase 2
Completed
- Conditions
- Hypercholesterolemia
- Interventions
- Registration Number
- NCT00677248
- Lead Sponsor
- Karo Bio AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 4 Eprotirome and ezetimibe Eprotirome dose 3 and ezetimibe 3 Eprotirome and ezetimibe Eprotirome dose 2 and ezetimibe 1 Ezetimibe and placebo Ezetimibe and placebo 2 Eprotirome and ezetimibe Eprotirome dose 1 and ezetimibe
- Primary Outcome Measures
Name Time Method LDL cholesterol 10 weeks
- Secondary Outcome Measures
Name Time Method Triglycerides 10 weeks
Trial Locations
- Locations (1)
Karo Bio AB
🇸🇪HUddinge, Sweden