Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
Condition: Obesity; Overweight
MeSH terms: Overweight
Intervention: NB32; PBO; Weight Management Program
Intervention description: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.; Placebo. Administered in addition to the weight management program.; A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
Intervention MeSH terms: Bupropion hydrochloride, naltrexone hydrochoride drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8910.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Body Weight; Bupropion; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Endocrine System Diseases; Glucose Metabolism Disorders; Heart Diseases; Metabolic Diseases; Narcotic Antagonists; Naltrexone; Nutrition Disorders; Obesity; Overnutrition; Overweight

Summary:

      The purpose of this study is to determine the effects of NB relative to placebo on major
      adverse cardiovascular events (MACE) such as cardiovascular death, non-fatal myocardial
      infarction, and non-fatal stroke in overweight and obese subjects who are at a higher risk of
      having these events because they have diabetes and/or other cardiovascular risk factors.
    

Eligibility criteria:

        Inclusion Criteria:

          1. ≥50 years of age (women) or ≥45 years of age (men)

          2. Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2

          3. Waist circumference ≥88 cm (women) or ≥102 cm (men)

          4. At increased risk of adverse cardiovascular outcomes:

               -  Cardiovascular disease (confirmed diagnosis or at high likelihood of
                  cardiovascular disease) with at least one of the following:

                    -  History of documented myocardial infarction >3 months prior to screening

                    -  History of coronary revascularization

                    -  History of carotid or peripheral revascularization

                    -  Angina with ischemic changes (resting ECG), ECG changes on a graded exercise
                       test (GXT), or positive cardiac imaging study

                    -  Ankle brachial index <0.9 (by simple palpation) within prior 2 years

                    -  ≥50% stenosis of a coronary, carotid, or lower extremity artery within prior
                       2 years

        AND/OR

          -  Type 2 diabetes mellitus with at least 2 of the following:

               -  Hypertension (controlled with or without pharmacotherapy at <145/95 mm Hg)

               -  Dyslipidemia requiring pharmacotherapy

               -  Documented low HDL cholesterol (<50 mg/dL in women or <40 mg/dL in men) within
                  prior 12 months

               -  Current tobacco smoker

        Exclusion Criteria:

          1. Myocardial infarction within 3 months prior to screening

          2. Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading
             scheme

          3. Clinical history of cerebrovascular disease (stroke)

          4. History of tachyarrhythmia other than sinus tachycardia

          5. Planned bariatric surgery, cardiac surgery, or coronary angioplasty

          6. History of seizures (including febrile seizures), cranial trauma, or other conditions
             that predispose the subject to seizures

          7. History of mania or current diagnosis of active psychosis, active bulimia or anorexia
             nervosa (binge eating disorder is not exclusionary)

          8. Any condition with life expectancy anticipated to be less than 4 years (e.g.,
             congestive heart failure NYHA Class 3 or 4)