Safety and Efficacy of APD356 in the Treatment of Obesity

Sponsor

Eisai Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00116740

Collaborator

(none)

400

Enrollment

Location

Duration (Months)

79.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: APD356	Phase 2

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Study Completion Date :

Nov 1, 2005

Outcome Measures

Primary Outcome Measures

Change in body weight []

Secondary Outcome Measures

Safety []
Changes in waist circumference, hip circumference, and waist/hip ratio []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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