Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects
- Conditions
- ObesityOverweight
- Interventions
- Registration Number
- NCT01764386
- Lead Sponsor
- Orexigen Therapeutics, Inc
- Brief Summary
The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 242
- Female or male, 18 to 60 years old
- Body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 for subjects with uncomplicated obesity, or BMI ≥27 kg/m2 and ≤45 kg/m2 for subjects with dyslipidemia and/or controlled hypertension
- History of type 1 or type 2 diabetes mellitus diagnosis
- Myocardial infarction within 6 months prior to screening
- Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
- Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic strokes (i.e., transient ischemic attack is not exclusionary)
- History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that predispose subjects to seizures
- Past or planned surgical or device intervention (e.g., gastric banding) for obesity
- Chronic use or positive screen for opioids
- Regular use of tobacco products
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NB + CLI NB Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI) NB + CLI CLI Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI) Usual Care Usual Care Usual Care (self-directed lifestyle intervention) Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.
- Primary Outcome Measures
Name Time Method Percent Change in Body Weight From Baseline (Day 1) to Week 26 Baseline to Week 26
- Secondary Outcome Measures
Name Time Method Change in Waist Circumference From Baseline to Week 26 Baseline to Week 26 Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26 Baseline to Week 26 Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26 Baseline to Week 26 Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26 Baseline to Week 26 Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26 Baseline to Week 26 Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26 Baseline to Week 26 Change in Systolic Blood Pressure From Baseline to Week 26 Baseline to Week 26 Change in Diastolic Blood Pressure From Baseline to Week 26 Baseline to Week 26 Change in Fasting Plasma Glucose From Baseline to Week 26 Baseline to Week 26 Change in Heart Rate From Baseline to Week 26 Baseline to Week 26 Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26 Baseline to Week 26 HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose \* Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.
Change in Fasting Triglycerides From Baseline to Week 26 Baseline to Week 26 Change Fasting Insulin From Baseline to Week 26 Baseline to Week 26 Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26 Baseline to Week 26 The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.
Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26 Baseline to Week 26 Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.
Absolute Change in Body Weight From Baseline to Week 26 Baseline to Week 26 Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26 Baseline to Week 26 Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment.
Trial Locations
- Locations (12)
Radiant Research-Akron
🇺🇸Akron, Ohio, United States
PMG Research of Winston-Salem
🇺🇸Hickory, North Carolina, United States
PMG Research of Salisbury
🇺🇸Salisbury, North Carolina, United States
PMG Research of Wilmington, LLC
🇺🇸Wilmington, North Carolina, United States
PMG Research of Raleigh
🇺🇸Raleigh, North Carolina, United States
Radiant Research, Inc.
🇺🇸Columbus, Ohio, United States
Radiant Research, Greer
🇺🇸Greer, South Carolina, United States
Radiant Research Dallas-North
🇺🇸Dallas, Texas, United States
PMG Research of Bristol
🇺🇸Bristol, Tennessee, United States
PMG Research of Charleston
🇺🇸Mount Pleasant, South Carolina, United States
Radiant Research, SLC
🇺🇸Salt Lake City, Utah, United States
Radiant Research
🇺🇸Anderson, South Carolina, United States