drugset / Trial / NCT00677248

LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe

NCT00677248

Phase 2 Completed 120 enrolled Karo Bio AB
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2008-04
Primary completion
2008-09
Completion
2008-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Eprotirome Small molecule
Background Ezetimibe Unknown

Indications