Novel Evaluation With QGC001 in Hypertensive Overweight Patients of Multiple Ethnic Origins

QGC001 is a prodrug of the specific and selective APA inhibitor, EC33, and is the prototype of a new class of centrally-acting anti-hypertensive agents called brain APA inhibitors. Inhibition of brain APA, which converts Ang II into Ang III, has emerged as a novel anti hypertensive treatment, as demonstrated in several experimental animal models. QGC001's anti-hypertensive effect is in part due to: 1) a decrease in arginine vasopressin release in the blood circulation, increasing diuresis, which reduces the size of body fluid compartment; and 2) a reduction in the sympathetic tone, leading to subsequent decreases in vascular resistances. This study is an open-label, dose-titrating safety and efficacy study of QGC001 administered PO, BID, over 8 weeks in hypertensive overweight subjects of multiple ethnic and racial groups in the United States. The primary objective of this study is to assess the effects of twice daily (BID) administration of oral (PO) QGC001 (250 mg BID, 500 mg BID, and 500 mg BID + hydrochlorothiazide (HCTZ) 25 mg once daily \[QD\]) on blood pressure (BP) over 8 weeks in hypertensive overweight/obese subjects of multiple races/ethnicities.