Safety and Efficacy of APD356 in the Treatment of Obesity

Completed · Phase 2

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00116740

Run by

Eisai Inc.

People needed

400

Starts

2005-06-01

Expected to finish

2005-11-01

Last updated by the study team

2019-09-12

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or nonpregnant, nonlactating females aged 18-65 years (inclusive)
• Body mass index (BMI) of 30-45 kg/m2
• Non-smoker
• 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

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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