Try our beta test site

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

This study has been terminated.
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc Identifier:
First received: May 14, 2012
Last updated: April 26, 2016
Last verified: April 2016
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.

Condition Intervention Phase
Drug: NB32
Drug: PBO
Behavioral: Weight Management Program
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • Time from treatment period randomization to the first confirmed occurrence of MACE [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]

Secondary Outcome Measures:
  • Time from treatment period randomization to the first confirmed occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or nonfatal unstable angina requiring hospitalization [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
  • Time from treatment period randomization to the confirmed occurrence of cardiovascular death (including fatal myocardial infarction, fatal stroke) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
  • Time from treatment period randomization to the first confirmed occurrence of myocardial infarction (nonfatal or fatal) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]
  • Time from treatment period randomization to the first confirmed occurrence of stroke (nonfatal or fatal) [ Time Frame: Day 1 to first confirmed occurrence, assessed up to 4 years ]

Enrollment: 8910
Study Start Date: June 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB32 Drug: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
Other Name: CONTRAVE
Behavioral: 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.
Other Name: WeightMate (Tm)
Placebo Comparator: PBO Drug: PBO
Placebo. Administered in addition to the weight management program.
Behavioral: 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.
Other Name: WeightMate (Tm)


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01601704

  Hide Study Locations
United States, Alabama
Birmingham, Alabama, United States
Dothan, Alabama, United States
Mobile, Alabama, United States
Scottsboro, Alabama, United States
United States, Arizona
Chandler, Arizona, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Tuscson, Arizona, United States
United States, Arkansas
Little Rock, Arkansas, United States
United States, California
Anaheim, California, United States
Carmichael, California, United States
Escondido, California, United States
Fresno, California, United States
Harbor City, California, United States
Huntington Beach, California, United States
La Jolla, California, United States
Lomita, California, United States
Los Angeles, California, United States
Paramount, California, United States
Pasadena, California, United States
Riverside, California, United States
Sacramento, California, United States
Santa Rosa, California, United States
Spring Valley, California, United States
Thousand Oaks, California, United States
Torrance, California, United States
West Hills, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Golden, Colorado, United States
Wheat Ridge, Colorado, United States
United States, Connecticut
Norwalk, Connecticut, United States
Stamford, Connecticut, United States
United States, Delaware
Wilmington, Delaware, United States
United States, District of Columbia
Washington, District of Columbia, United States
United States, Florida
Boynton Beach, Florida, United States
Brooksville, Florida, United States
Clearwater, Florida, United States
Deland, Florida, United States
Delray Beach, Florida, United States
Gainesville, Florida, United States
Jacksonville Beach, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
New Smyrna Beach, Florida, United States
Oakland Park, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Pinellas Park, Florida, United States
Saint Petersburg, Florida, United States
Vero beach, Florida, United States
Wellington, Florida, United States
Winter Haven, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
Austell, Georgia, United States
Columbus, Georgia, United States
Lawrenceville, Georgia, United States
Riverdale, Georgia, United States
Savannah, Georgia, United States
Stockbridge, Georgia, United States
United States, Hawaii
Honolulu, Hawaii, United States
United States, Idaho
Meridian, Idaho, United States
United States, Illinois
Chicago, Illinois, United States
Gurnee, Illinois, United States
Melrose Park, Illinois, United States
United States, Indiana
Bloomington, Indiana, United States
Brownsburg, Indiana, United States
Elwood, Indiana, United States
Evansville, Indiana, United States
Hammond, Indiana, United States
South Bend, Indiana, United States
Valparaiso, Indiana, United States
United States, Iowa
Ames, Iowa, United States
Council Bluffs, Iowa, United States
Des Moines, Iowa, United States
West Des Moines, Iowa, United States
United States, Kansas
Overland Park, Kansas, United States
Wichita, Kansas, United States
United States, Kentucky
Crestview Hills, Kentucky, United States
Louisville, Kentucky, United States
Mount Sterling, Kentucky, United States
United States, Louisiana
Alexandria, Louisiana, United States
Baton Rouge, Louisiana, United States
Monroe, Louisiana, United States
Natchitoches, Louisiana, United States
United States, Maine
Auburn, Maine, United States
Bangor, Maine, United States
United States, Maryland
Baltimore, Maryland, United States
Columbia, Maryland, United States
Elkridge, Maryland, United States
Lutherville, Maryland, United States
Salisbury, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
Brockton, Massachusetts, United States
Fall River, Massachusetts, United States
Haverhill, Massachusetts, United States
Methuen, Massachusetts, United States
United States, Michigan
Bingham Farms, Michigan, United States
Dearbon, Michigan, United States
Kalamazoo, Michigan, United States
Midland, Michigan, United States
Saginaw, Michigan, United States
Southfield, Michigan, United States
Stevensville, Michigan, United States
United States, Minnesota
Edina, Minnesota, United States
Rochester, Minnesota, United States
United States, Mississippi
Jackson, Mississippi, United States
Olive Branch, Mississippi, United States
Tupelo, Mississippi, United States
United States, Missouri
Saint Louis, Missouri, United States
United States, Montana
Butte, Montana, United States
Missoula, Montana, United States
United States, Nebraska
Fremont, Nebraska, United States
Grand Island, Nebraska, United States
Omaha, Nebraska, United States
United States, Nevada
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Reno, Nevada, United States
Sparks, Nevada, United States
United States, New Jersey
Belvidere, New Jersey, United States
Edison, New Jersey, United States
Elizabeth, New Jersey, United States
Elmer, New Jersey, United States
Linden, New Jersey, United States
Ridgewood, New Jersey, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Bronx, New York, United States
Endwell, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Staten Island, New York, United States
Syracuse, New York, United States
Williamsville, New York, United States
United States, North Carolina
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Durham, North Carolina, United States
Elizabeth City, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Hickory, North Carolina, United States
Morganton, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Ohio
Akron, Ohio, United States
Beachwood, Ohio, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Delaware, Ohio, United States
Kettering, Ohio, United States
Marion, Ohio, United States
Mentor, Ohio, United States
Willoughby Hills, Ohio, United States
United States, Oklahoma
Oklahoma City, Oklahoma, United States
United States, Oregon
Medford, Oregon, United States
Portland, Oregon, United States
United States, Pennsylvania
Altoona, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Danville, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Ephrata, Pennsylvania, United States
Jersey Shore, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Lansdale, Pennsylvania, United States
Norristown, Pennsylvania, United States
Scottdale, Pennsylvania, United States
Sellersville, Pennsylvania, United States
State College, Pennsylvania, United States
West Reading, Pennsylvania, United States
Wilkes-Barre, Pennsylvania, United States
United States, South Carolina
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Greer, South Carolina, United States
Hodges, South Carolina, United States
Laurens, South Carolina, United States
Mount Pleasant, South Carolina, United States
United States, South Dakota
Rapid City, South Dakota, United States
United States, Tennessee
Bristol, Tennessee, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Jackson, Tennessee, United States
Kingsport, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
United States, Texas
Beaumont, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Hurst, Texas, United States
Lake Jackson, Texas, United States
McKinney, Texas, United States
San Antonio, Texas, United States
Schertz, Texas, United States
Tomball, Texas, United States
Waco, Texas, United States
United States, Utah
Bountiful, Utah, United States
Draper, Utah, United States
Murray, Utah, United States
Ogden, Utah, United States
Orem, Utah, United States
Salt Lake City, Utah, United States
West Jordan, Utah, United States
United States, Virginia
Alexandria, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Winchester, Virginia, United States
United States, Washington
Seattle, Washington, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Walla Walla, Washington, United States
United States, Wisconsin
Green Bay, Wisconsin, United States
Kenosha, Wisconsin, United States
Madison, Wisconsin, United States
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Study Director: Medical Director Clinical Science Takeda
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Orexigen Therapeutics, Inc Identifier: NCT01601704     History of Changes
Other Study ID Numbers: NB-CVOT  The Light Study  U1111-1162-4981 
Study First Received: May 14, 2012
Last Updated: April 26, 2016

Keywords provided by Orexigen Therapeutics, Inc:
Body Weight
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Heart Diseases
Metabolic Diseases
Narcotic Antagonists
Nutrition Disorders

Additional relevant MeSH terms:
Body Weight
Signs and Symptoms
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors processed this record on February 20, 2017