Safety and Efficacy of APD356 in the Treatment of Obesity

Phase 2

Completed

• Conditions: Obesity

• Registration Number: NCT00104507
• Lead Sponsor: Eisai Inc.

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 preliminary assessment of the safety and efficacy of APD356, when administered daily for 28 days, in obese subjects who are otherwise healthy.

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 28 days, to uncomplicated obese, male and nonpregnant, nonlactating, female volunteers, aged 18 to 65 years. Approximately 400 subjects will be enrolled.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-03-01
• Study First Submitted QC: 2005-03-01
• Study First Posted: 2005-03-02
• Study Completion: 2005-05
• Status Verified: 2006-12
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in body weight

Secondary Outcome Measures

Name	Time	Method
Safety
Changes in waist circumference, hip circumference and waist/hip ratio

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States