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

Completed · Phase 3 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.

Key facts

Study ID: NCT00456521
Run by: Orexigen Therapeutics, Inc
People needed: 793
Starts: 2007-03-01
Expected to finish: 2008-12-01
Last updated by the study team: 2014-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Female or male subjects aged 18 to 65 years (inclusive)
Body mass index (weight [kg]/height [m²]) ≥30 and ≤45 kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45 kg/m² for subjects with controlled hypertension and/or dyslipidemia
Non-smoker and had not used tobacco or nicotine products for at least 6 months before screening
Normotensive (systolic ≤140 mm Hg and diastolic ≤90 mm Hg). Anti-hypertensive medications were allowed with the exception of alpha-adrenergic blockers, beta-blockers, and clonidine. Medical regimen was to be stable for at least 8 weeks.
Low-density lipoprotein level <190 mg/dL and triglycerides level <400 mg/dL. Medications for the treatment of dyslipidemia were allowed as long as the medical regimen had been stable for at least 8 weeks.
No clinically significant abnormality of serum albumin, blood urea nitrogen (BUN), creatinine, bilirubin, calcium and phosphorus
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 2.5 times upper limit of normal (ULN)
No clinically significant abnormality of hematocrit, white blood cell (WBC) count, WBC differential, or platelets
Fasting glucose ≤126 mg/dL and not receiving hypoglycemic agents
No clinically significant abnormality on urinalysis
Thyroid stimulating hormone (TSH) within 1.5 times ULN or normal triiodothyronine (T3), if TSH was below normal limits
Female subjects of childbearing potential had a negative serum pregnancy test
An IDS-SR score <2 on individual items: 5 (sadness), 6 (irritability), 7 (anxiety/tension), and 18 (suicidality) and an IDS-SR total score <30
Female subjects of childbearing potential were non-lactating and agreed to continue to use effective contraception throughout the study and 30 days after discontinuation of study drug
Completed a food diary for 6 of 7 consecutive days during screening
Able to comply with all required study procedures and schedule
Able to speak and read English
Provided written informed consent

You may not qualify if…

Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established polycystic ovary syndrome)
Serious medical condition (including but not limited to renal or hepatic insufficiency; congestive heart failure, angina pectoris, myocardial infarction, stroke, claudication, or acute limb ischemia; history of malignancy with exception of non-melanoma skin cancer or surgically cured cervical cancer)
Serious psychiatric illness (e.g., lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, e.g., borderline; severe major depressive disorder, recent [previous 6 months] suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness)
Response to the bipolar disorder questions that indicated the presence of bipolar disorder.
Required medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months
History of drug or alcohol abuse or dependence within 1 year
Type I or Type II diabetes mellitus
Baseline ECG with a corrected QT (QTc) interval (using Bazett's formula >450 millisecond (msec) [males] and >470 msec [females]) or the presence of any clinically significant cardiac abnormalities, including but not limited to patterns consistent with myocardial ischemia, electrolyte abnormalities, or atrial or ventricular dysrhythmia or significant conduction abnormalities
Received excluded concomitant medications: any psychotropic agents (including antipsychotic, antidepressant, anxiolytic, mood stabilizer or anticonvulsant agents) with the exception of low-dose benzodiazepine or hypnotic agents for the treatment of insomnia; any anorectic or weight loss agents; any over-the-counter dietary supplements with psychoactive, appetite or weight effects; alpha-adrenergic blockers; beta-blockers; clonidine; coumadin; theophylline; cimetidine; oral corticosteroids; topiramate, Depo-Provera®; smoking cessation agents; regular use of opioid or opioid-like analgesics
History of surgical or device (e.g., lap band) intervention for obesity
History of seizures of any etiology, or of predisposition to seizures (e.g., history of cerebrovascular accident, head trauma with >5 minutes loss of consciousness, concussion symptoms lasting >15 minutes, brain surgery, skull fracture, subdural hematoma, or febrile seizures)
History of treatment with bupropion or naltrexone within the preceding 12 months
History of hypersensitivity or intolerance to bupropion or naltrexone
Used drugs, herbs, or dietary supplements believed to significantly affect body weight or participated in a weight loss management program within one month prior to baseline
Loss or gained >4.0 kilograms within the previous 3 months
Females who were pregnant or breast-feeding or planning to become pregnant during the study period or within 30 days of discontinuing study drug
Planned surgical procedure that could impact the conduct of the study
Received any investigational drug or used an experimental device or procedure within the previous 30 days
Participated in any previous clinical trial conducted by Orexigen
Had any condition that in the opinion of the investigator made the subject unsuitable for inclusion into the study

Where it is running

University of California, San Diego: Dept of Family & Preventive Medicine — La Jolla, California, United States
Center for Human Nutrition, University of Colorado Health Services Center — Denver, Colorado, United States
Univ. of Florida, College of Public Health, and Health Professions — Gainesville, Florida, United States
Washington Univ. Center for Human Nutrition — St Louis, Missouri, United States
New York Obesity Research Center, St. Luke's-Roosevelt Hospital Center — New York, New York, United States
Center for Weight and Eating Disorders, School of Med., University of Penn. — Philadelphia, Pennsylvania, United States
Center for Obesity Research and Education, Temple University — Philadelphia, Pennsylvania, United States
Medical University of S. Carolina Weight Management Center — Charleston, South Carolina, United States
Behavioral Medicine Research Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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