NCT00116740

Safety and Efficacy of APD356 in the Treatment of Obesity

A 12-Week, Dose-Ranging, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 400 (planned)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	APD356

Timeline

• Start date: 2005-06-01
• Completion: 2005-11-01
• First posted: 2005-07-01
• Last updated: 2019-09-12

Locations

1 site across 1 country: United States