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: NCT00104507
Recruitment Status : Completed
First Posted : March 2, 2005
Last Update Posted : February 2, 2010
Information provided by:
Arena Pharmaceuticals

March 1, 2005
March 2, 2005
February 2, 2010
December 2004
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Change in body weight
Same as current
Complete list of historical versions of study NCT00104507 on Archive Site
  • Safety
  • Changes in waist circumference, hip circumference and waist/hip ratio
Same as current
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Safety and Efficacy of APD356 in the Treatment of Obesity
A 4-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients

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.

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.
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Drug: APD356
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2005
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  • Healthy male or nonpregnant, nonlactating females aged between 18 and 65 years (inclusive)
  • Body Mass Index (BMI) of 30-45 Kg/m^2.
  • Non-smoker
  • No concomitant medications
  • No past treatment with drugs associated with the development of pulmonary hypertension or cardiac valvular insufficiency
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Arena Pharmaceuticals
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Study Chair: William R Shanahan, Jr, MD Arena Pharmaceuticals
Arena Pharmaceuticals
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP