Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)

Orexigen

Status and phase: Terminated; Phase 3

Conditions: Overweight; Obesity

Treatments: Behavioral: Weight Management Program; Drug: NB32; Drug: PBO

Study type: Interventional

Funder types: Industry

Identifiers

NCT01601704

U1111-1162-4981 (Registry Identifier)

The Light Study (Other Identifier)

NB-CVOT

Details and patient eligibility

About

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.

Enrollment: 8,910 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,910 participants in 2 patient groups, including a placebo group

NB32

Experimental group

Treatment:

Behavioral: Weight Management Program

Drug: NB32

PBO

Placebo Comparator group

Treatment:

Drug: PBO

Behavioral: Weight Management Program