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
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 4/21/2016 |
| Start Date: | February 2013 |
| End Date: | September 2014 |
A Multicenter, Randomized, Open-Label, Controlled, 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 (The Ignite Study)
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).
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).
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
We found this trial at
15
sites
PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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