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Safety and Efficacy of APD356 in the Treatment of Obesity

This study has been completed.
Information provided by:
Arena Pharmaceuticals Identifier:
First received: June 30, 2005
Last updated: March 24, 2010
Last verified: December 2006

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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00116740

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00116740     History of Changes
Other Study ID Numbers: APD356-004
Study First Received: June 30, 2005
Last Updated: March 24, 2010

Keywords provided by Arena Pharmaceuticals:
Appetite suppressant
Weight Loss

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on September 21, 2017