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Safety and Efficacy of APD356 in the Treatment of Obesity

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ClinicalTrials.gov Identifier: NCT00116740
Recruitment Status : Completed
First Posted : July 1, 2005
Last Update Posted : March 25, 2010
Sponsor:
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.

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

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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
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

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 ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov 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:
Serotonin
5-HT2c
Satiety
Obesity
Appetite suppressant
Weight Loss
Overweight

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