Safety and Efficacy of APD356 in the Treatment of Obesity - Full Text View

Sponsored by:	Arena Pharmaceuticals
Information provided by:	Arena Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00116740

Purpose

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	Intervention	Phase
Obesity	Drug: APD356	Phase II

MedlinePlus related topics: Obesity

Drug Information available for: Serotonin APD-356

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Arena Pharmaceuticals:

Primary Outcome Measures:

Change in body weight

Secondary Outcome Measures:

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

Estimated Enrollment:	400
Study Start Date:	June 2005
Estimated Study Completion Date:	November 2005

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116740

Locations

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808

Sponsors and Collaborators

Arena Pharmaceuticals

Investigators

Study Chair:

William R Shanahan, Jr., MD

Arena Pharmaceuticals

More Information

obesity information This link exits the ClinicalTrials.gov site

N. American Association for the Study of Obesity web page This link exits the ClinicalTrials.gov site

sponsor company web page This link exits the ClinicalTrials.gov site

Pennington Biomedical Research Center home web page This link exits the ClinicalTrials.gov site

Study ID Numbers:	APD356-004
Study First Received:	June 30, 2005
Last Updated:	December 21, 2006
ClinicalTrials.gov Identifier:	NCT00116740
Health Authority:	United States: Food and Drug Administration

Keywords provided by Arena Pharmaceuticals:

Serotonin
5-HT2c
Satiety
Obesity

Appetite suppressant
Weight Loss
Overweight

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Nutrition Disorders
Overnutrition
Overweight
Serotonin

ClinicalTrials.gov processed this record on January 14, 2009