NCT00532779

Completed

Phase 3

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

Orexigen Therapeutics, Inc31 sites in 1 country1,742 target enrollmentOctober 2007

InterventionsNaltrexone SR 16 mg/Bupropion SR 360 mg /day Ancillary therapy Naltrexone SR 32 mg/Bupropion SR 360 mg /day Placebo

DrugsNaltrexone SR 16 mg/Bupropion SR 360 mg /day Naltrexone SR 32 mg/Bupropion SR 360 mg /day Placebo

Overview

Phase: Phase 3
Intervention: Naltrexone SR 16 mg/Bupropion SR 360 mg /day
Conditions: Obesity
Sponsor: Orexigen Therapeutics, Inc
Enrollment: 1742
Locations: 31
Primary Endpoint: Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2007

End Date

May 2009

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Orexigen Therapeutics, Inc

Responsible Party

Sponsor

Eligibility Criteria

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;

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;

Arms & Interventions

NB16

Naltrexone SR 16 mg/Bupropion SR 360 mg /day with ancillary therapy

Intervention: Naltrexone SR 16 mg/Bupropion SR 360 mg /day

NB16

Naltrexone SR 16 mg/Bupropion SR 360 mg /day with ancillary therapy

Intervention: Ancillary therapy

NB32

Naltrexone SR 32 mg/Bupropion SR 360 mg /day with ancillary therapy

Intervention: Naltrexone SR 32 mg/Bupropion SR 360 mg /day

NB32

Naltrexone SR 32 mg/Bupropion SR 360 mg /day with ancillary therapy

Intervention: Ancillary therapy

Placebo

Placebo with ancillary therapy

Intervention: Placebo

Placebo

Placebo with ancillary therapy

Intervention: Ancillary therapy

Outcomes

Primary Outcomes

Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease

Time Frame: Baseline, 56 weeks

Co-primary: Body Weight- Mean Percent Change

Time Frame: Baseline, 56 weeks

Secondary Outcomes

Change in Fasting Triglycerides Levels, Using Log-transformed Data(Baseline, 56 weeks)
Body Weight- Proportion of Subjects With ≥10% Decrease(Baseline, 56 weeks)
Change in Fasting HDL Cholesterol Levels(Baseline, 56 weeks)
Change in Waist Circumference(Baseline, 56 weeks)
Change in Fasting Blood Glucose Levels(Baseline, 56 weeks)
Change in HOMA-IR Levels, Using Log-transformed Data(Baseline, 56 weeks)
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire(Baseline, 56 weeks)
Change in IWQOL-Lite Total Scores(Baseline, 56 weeks)
Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data(Baseline, 56 weeks)
Change in Fasting Insulin Levels, Using Log-transformed Data(Baseline, 56 weeks)
Change in Fasting LDL Cholesterol Levels(Baseline, 56 weeks)
Change in Systolic Blood Pressure(Baseline, 56 weeks)
Change in IDS-SR Total Scores(Baseline, 56 weeks)
Change in Diastolic Blood Pressure(Baseline, 56 weeks)
Change in Food Craving Inventory Sweets Subscale Score(Baseline, 56 weeks)
Change in Food Craving Inventory Carbohydrates Subscale Score(Baseline, 56 weeks)