Clinical Trials/NCT00567255

NCT00567255

Completed

Phase 3

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

Orexigen Therapeutics, Inc34 sites in 1 country1,496 target enrollmentDecember 2007

ConditionsObesity Overweight

InterventionsNaltrexone SR 32 mg/bupropion SR 360 mg/day Ancillary therapy Placebo

DrugsNaltrexone SR 32 mg/bupropion SR 360 mg/day Placebo

Overview

Phase: Phase 3
Intervention: Naltrexone SR 32 mg/bupropion SR 360 mg/day
Conditions: Obesity
Sponsor: Orexigen Therapeutics, Inc
Enrollment: 1496
Locations: 34
Primary Endpoint: Co-primary: Body Weight- Mean Percent Change From Baseline to Week 28
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 the combination of naltrexone SR and bupropion SR is 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 naltrexone alone, bupropion SR alone or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy 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

December 2007

End Date

June 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 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 obesity with controlled hypertension and/or dyslipidemia
•Normotensive (systolic ≤140 mm Hg and diastolic ≤90 mm Hg). Anti-hypertensive medications were allowed with the exception of alpha-adrenergic blockers and clonidine. Medical regimen was to be stable for at least 6 weeks prior to randomization.
•Medications for the treatment of dyslipidemia were allowed as long as the medical regimen had 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 (BUN), creatinine, bilirubin, sodium, potassium, chloride, calcium or 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 and fasting triglycerides level \<400 mg/dL
•No clinically significant abnormality on urinalysis

Exclusion Criteria

•Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome)
•Serious medical condition (including but not limited to renal or hepatic insufficiency; Class III or IV congestive heart failure, history of angina pectoris, myocardial infarction, 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
•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
•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 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 I or Type II diabetes mellitus
•Screening 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

Arms & Interventions

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- Mean Percent Change From Baseline to Week 28

Time Frame: Baseline, 28 weeks

Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 28

Time Frame: Baseline, 28 weeks

Secondary Outcomes

Body Weight- Mean Percent Change From Baseline to Week 56(Baseline, 56 weeks)
Body Weight- Proportion of Subjects With ≥5% Decrease From Baseline to Week 56(Baseline, 56 weeks)
Body Weight- Proportion of Subjects With ≥10% Decrease From Baseline to Week 28(Baseline, 28 weeks)
Change in Waist Circumference(Baseline, 28 weeks)
Change in Fasting HDL Cholesterol Levels(Baseline, 28 weeks)
Change in Fasting Triglycerides Levels, Using Log-transformed Data(Baseline, 28 weeks)
Change in IWQOL-Lite Total Scores(Baseline, 28 weeks)
Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data(Baseline, 28 weeks)
Change in Fasting Insulin Levels, Using Log-transformed Data(Baseline, 28 weeks)
Change in Fasting Blood Glucose Levels(Baseline, 28 weeks)
Change in HOMA-IR Levels, Using Log-transformed Data(Baseline, 28 weeks)
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire(Baseline, 28 weeks)
Change in Fasting LDL Cholesterol Levels(Baseline, 28 weeks)
Change in Systolic Blood Pressure(Baseline, 28 weeks)
Change in Diastolic Blood Pressure(Baseline, 28 weeks)
Change in IDS-SR Total Score(Baseline, 28 weeks)
Change in Food Craving Inventory Sweets Subscale Score(Baseline, 28 weeks)
Change in Food Craving Inventory Carbohydrates Subscale Score(Baseline, 28 weeks)