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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Ezetimibe and placebo |
|
| 2 | Experimental | Eprotirome dose 1 and ezetimibe |
|
| 3 | Experimental | Eprotirome dose 2 and ezetimibe |
|
| 4 | Experimental | Eprotirome dose 3 and ezetimibe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ezetimibe and placebo | Drug | Placebo or three different doses of eprotirome added to ezetimibe treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Triglycerides | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens D Kristensen, MD, PhD | Karo Bio AB | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karo Bio AB | Huddinge | Sweden |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| D015228 | Hypertriglyceridemia |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| C526273 | 3-((3,5-dibromo-4-(4-hydroxy-3-(1-methylethyl)phenoxy)phenyl)amino)-3-oxopropanoic acid |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Eprotirome and ezetimibe | Drug | Placebo or three different doses of eprotirome added to ezetimibe treatment |
|