Independent directory Public ClinicalTrials.gov records United States
ClinicalTrials.gov record
Completed Phase 3 Interventional Results available

A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program

ClinicalTrials.gov ID: NCT00456521

Public ClinicalTrials.gov record NCT00456521. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 9:49 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program

Study identification

NCT ID
NCT00456521
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Orexigen Therapeutics, Inc
Industry
Enrollment
793 participants

Conditions and interventions

Interventions

  • Naltrexone SR 32 mg/ bupropion SR 360 mg/ day Drug
  • Placebo Drug
  • Intensive group lifestyle modification counseling Behavioral

Drug · Behavioral

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2007
Primary completion
Nov 30, 2008
Completion
Nov 30, 2008
Last update posted
Dec 16, 2014

2007 – 2008

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
University of California, San Diego: Dept of Family & Preventive Medicine La Jolla California 92093
Center for Human Nutrition, University of Colorado Health Services Center Denver Colorado 80220
Univ. of Florida, College of Public Health, and Health Professions Gainesville Florida 32611
Washington Univ. Center for Human Nutrition St Louis Missouri 63110
New York Obesity Research Center, St. Luke's-Roosevelt Hospital Center New York New York 10025
Center for Weight and Eating Disorders, School of Med., University of Penn. Philadelphia Pennsylvania 19104
Center for Obesity Research and Education, Temple University Philadelphia Pennsylvania 19140
Medical University of S. Carolina Weight Management Center Charleston South Carolina 29425
Behavioral Medicine Research Center Houston Texas 77030

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00456521, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 16, 2014 · Synced Jul 22, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00456521 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →