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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR

Phase 3
45 Years
Open (Enrolling)
Obesity, Overweight

Thank you

Trial Information

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Occurrence of Major Adverse Cardiovascular Events (MACE) in Overweight and Obese Subjects With Cardiovascular Risk Factors Receiving Naltrexone SR/Bupropion SR

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


- 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

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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Time from treatment period randomization to the first confirmed occurrence of MACE

Outcome Time Frame:

Day 1 to first confirmed occurrence, assessed up to 4 years

Safety Issue:


Principal Investigator

Senior Vice President, Head of Global Development

Investigator Role:

Study Director

Investigator Affiliation:

Orexigen Therapeutics, Inc


United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

July 2017

Related Keywords:

  • Obesity
  • Overweight
  • 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
  • Obesity
  • Overweight



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