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A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE3

A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects

NCT00532779•Orexigen Therapeutics, Inc

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.

Detailed Description

Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Female and male subjects, 18 to 65 years of age;
•Have BMI ≥30 and ≤45kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45kg/m² for subjects with obesity and controlled hypertension and/or dyslipidemia;
•Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications are allowed with the exception of alpha-adrenergic blockers and clonidine; medical regimen must be stable for at least 6 weeks prior to randomization;
•Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks prior to randomization;
•Free of opioid medication for 7 days prior to randomization;
•No clinically significant abnormality of serum albumin, blood urea nitrogen, creatinine, bilirubin, sodium, potassium, chloride, calcium or phosphorus;
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 2.5 x upper limit of normal range (ULN);
•No clinically significant abnormality of hematocrit, white blood cell (WBC) count, white cell differential, or platelets;
•Fasting glucose \< 126 mg/dL on no hypoglycemic agents, fasting triglycerides \<400 mg/dL;
•No clinically significant abnormality on urinalysis;
+8 more criteria

Exclusion Criteria

•Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
•Serious medical conditions (including but not limited to ongoing renal or hepatic insufficiency, Class III or IV congestive heart failure; myocardial infarction, history of angina pectoris, claudication, or acute limb ischemia within the previous 6 months; lifetime history of stroke);
•History of malignancy within the previous 5 years with exception of non-melanoma skin cancer or surgically cured cervical cancer;
•A lifetime history of serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, or anorexia nervosa;
•Current serious psychiatric illness including severe personality disorder, (e.g. borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt, current active suicidal ideation, or recent hospitalization due to psychiatric illness;
•A response to bipolar disorder questions indicating the presence of bipolar disorder;
•In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization;
•History of drug or alcohol abuse or dependence (with the exception of nicotine dependence) within 1 year prior to study initiation;
•Type 1 or Type 2 diabetes mellitus;
•Screening ECG with a corrected QT interval by the method of Bazett (QTcB) \>450 msec (men) and \> 470 millisecond (msec) (women) 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;
+14 more criteria

Locations (34)

Radiant Research

Birmingham, Alabama, United States

SelfCenter, PC

Fairhope, Alabama, United States

Radiant Research, Phoenix Southeast

Chandler, Arizona, United States

Advanced Clinical Research Institute

Anaheim, California, United States

Advance Clinical Research Institute

Orange, California, United States

Scripps Clinic Del Mar

San Diego, California, United States

VA San Diego Healthcare System

San Diego, California, United States

Miami Research Associates

Miami, Florida, United States

University Clinical Research

Pembroke Pines, Florida, United States

Georgia Clinical Research

Atlanta, Georgia, United States

Key Dates

Start Date

October 1, 2007

Primary Completion Date

May 1, 2009

Completion Date

May 1, 2009

Last Updated

November 21, 2014

Enrollment

1,742

ACTUAL participants

Conditions

ObesityOverweight

Interventions

Naltrexone SR 16 mg/Bupropion SR 360 mg /day

DRUG

Naltrexone SR 32 mg/Bupropion SR 360 mg /day

DRUG

Placebo

DRUG

Ancillary therapy

BEHAVIORAL

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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Metabolic DiseaseObesity+4 more

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RECRUITINGNA

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects

Inclusion Criteria

Exclusion Criteria

Characterization of Patients With Uncommon Presentations and/or Uncommon Diseases Associated With the Cardiovascular System

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