Titan Pharmaceuticals Inc. has initiated a Phase II study of DITPA (3,5-diiodothyropropionic acid) in the treatment of elevated cholesterol levels. This study will evaluate the cholesterol-lowering properties of DITPA administered in combination with standard statin therapy, in individuals who are unable to achieve targeted cholesterol level reductions with statin therapy alone. This investigator-sponsored study is being conducted at The Johns Hopkins Medical Institutions in Baltimore, Maryland.

DITPA is a novel analogue of thyroid hormone, which in early human testing has shown the ability to reduce LDL cholesterol and triglyceride levels. Preclinical and preliminary clinical testing has shown that DITPA has reduced potential for increasing heart rate and metabolism, and it was selected for further development based upon these properties.

This 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 NCEP guidelines. The study will have 3 treatment groups, and individuals will receive one of two doses of DITPA, or placebo, for 12 weeks. The primary objective of the study is to evaluate DITPA as a cholesterol lowering agent in combination with standard therapy in patients with LDL cholesterol levels greater than the NCEP goals. Secondary objectives include evaluating the effect of DITPA on other lipid targets such as total cholesterol and triglyceride levels, and weight and waist circumference.

Recent data have indicated that further lowering of target LDL cholesterol level guidelines may be important in reducing the incidence of heart disease and stroke. Accordingly, the National Cholesterol Education Program (NCEP) has recently updated its guidelines to recommend that doctors target lower LDL cholesterol levels in their patients.

Treatment with statins is the mainstay of therapy for people needing to lower their LDL cholesterol. However, many such individuals do not achieve the NCEP recommended goals. More than 40% of all Americans have LDL cholesterol levels above the currently recommended target maximum level of 130 mg/dl, and 13 million Americans have coronary artery disease that could benefit from lipid modification therapy. To achieve LDL cholesterol goals, many of these individuals require additional treatment in combination with their standard statin therapy, according to the company release.