This study will evaluate the cholesterol-lowering properties of DITPA (3,5-diiodothyropropionic acid), administered in combination with standard statin therapy, in individuals who are unable to achieve targeted cholesterol level reductions with statin therapy alone.
Treatment with statins is the mainstay of therapy for people needing to lower their LDL cholesterol. However, many individuals do not achieve the recommended cholesterol levels even when using such therapy, meaning additional treatments may be required in combination with standard statin therapy.
DITPA is a novel analogue of thyroid hormone, which in early human testing has shown the ability to reduce LDL cholesterol and triglyceride levels. In a preliminary phase II clinical study in 22 patients with congestive heart failure, DITPA was well tolerated and demonstrated the ability to lower total cholesterol, LDL cholesterol, and triglyceride levels.
The new phase II, randomized, double-blind, placebo-controlled study will evaluate DITPA in 60 individuals receiving standard lipid-lowering therapy, whose LDL cholesterol levels are above National Cholesterol Education Program (NCEP) guidelines. The study will have three treatment groups, and individuals will receive one of two doses of DITPA, or placebo, for 12 weeks.
“Mounting evidence suggests that thyroid hormone analogues, such as DITPA, can harness the cholesterol lowering properties of naturally occurring thyroid hormones, but with a potentially improved safety profile,” stated Dr Paul Ladenson, professor and director of the division of endocrinology and metabolism at The Johns Hopkins Medical Institutions, and a lead investigator of the study.