Safety and Efficacy of APD356 in the Treatment of Obesity

This study has been completed.
Sponsor:
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00116740
First received: June 30, 2005
Last updated: March 24, 2010
Last verified: December 2006
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

  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
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, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by Arena Pharmaceuticals

Additional 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
Study First Received: June 30, 2005
Last Updated: March 24, 2010
Health Authority: United States: Food and Drug Administration

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
Appetite Depressants
Pamidronate
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014