LDL-Cholesterol Lowering Effect of KB2115 as Add on to Statin
Status:
Completed
Trial end date:
2008-09-01
Target enrollment:
Participant gender:
Summary
Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key
enzymes involved in synthesis, degradation, and lipid transport. However, the currently
marketed thyroid agonists are non-selective, and cannot be used for the treatment of
hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on
heart, bone, and muscle.
To take advantage of thyroid hormone effect on lipid metabolism for the treatment of
hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that
can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the
extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective.
The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to
low and middle doses of statin 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 at
doses between 25 and 100 µg and to define a clinically relevant dose or dose range for future
studies.