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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 a clinical 2-weeks studies demonstrated pronounced reduction of 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 monotherapy following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| Eprotirome dose 1 | Experimental |
| |
| Eprotirome dose 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Eprotirome | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Lipid variables, Thyroid hormone levels, Bone markers,DEXA, ECG, Echocardiography, liver enzymes | 12 week |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jens Kristensen | Huddinge | Sweden |
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| Placebo |
| Drug |
|
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| D013959 | Thyroid Diseases |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C526273 | 3-((3,5-dibromo-4-(4-hydroxy-3-(1-methylethyl)phenoxy)phenyl)amino)-3-oxopropanoic acid |
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