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Safety and Efficacy of APD356 in the Treatment of Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00116740
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : March 25, 2010
Information provided by:
Arena Pharmaceuticals

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
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 : June 2005
Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin

Primary Outcome Measures :
  1. Change in body weight

Secondary Outcome Measures :
  1. Safety
  2. Changes in waist circumference, hip circumference, and waist/hip ratio

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00116740

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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Arena Pharmaceuticals
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Study Chair: William R Shanahan, Jr., MD Arena Pharmaceuticals

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00116740     History of Changes
Other Study ID Numbers: APD356-004
First Posted: July 1, 2005    Key Record Dates
Last Update Posted: March 25, 2010
Last Verified: December 2006

Keywords provided by Arena Pharmaceuticals:
Appetite suppressant
Weight Loss

Additional relevant MeSH terms:
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Nutrition Disorders
Body Weight
Signs and Symptoms