This is a research study of an investigational drug, APD356, a novel, selective 5-HT2c
receptor agonist, in clinical development as a potential treatment for obesity.
The purpose of this study is to obtain a preliminary assessment of the safety and efficacy
of APD356, when administered daily for 12 weeks, in obese subjects who are otherwise
healthy. Subjects who are on concomitant medications for control of hypertension or blood
lipids may qualify.
This is a double-blind, placebo-controlled, randomized, parallel group study. Three
different doses of APD356 or placebo will be administered daily for 12 weeks, to obese, male
and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400
subjects will be enrolled.
- Healthy male or nonpregnant, nonlactating females aged 18-65 years (inclusive)
- Body mass index (BMI) of 30-45 kg/m2
- No concomitant medications other than hypertension medications (stable > 90 days)
and/or statins (stable > 90 days)
- No past treatment with drugs associated with the development of pulmonary
hypertension or cardiac valvular insufficiency
- No more than mild mitral valve regurgitation and absence of aortic valve
regurgitation upon screening echocardiogram