Safety and Efficacy of APD356 in the Treatment of Obesity
This study has been completed.
Sponsor:
Arena Pharmaceuticals
Information provided by:
Arena Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00116740
First received: June 30, 2005
Last updated: March 24, 2010
Last verified: December 2006
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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 |
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
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 June 18, 2013