Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
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
3 other identifiers
interventional
8,910
1 country
224
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Jun 2012
Typical duration for phase_3 obesity
224 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 14, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
February 27, 2017
CompletedFebruary 27, 2017
April 1, 2016
3.2 years
May 14, 2012
December 11, 2016
February 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE)
The primary endpoint is the time from randomization to the first confirmed occurrence of any event within the primary MACE composite (defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke). Due to early termination of the study, pre-planned 50% interim analysis is considered the primary analysis for outcome measures. The pre-planned 50% interim analysis was conducted when 50% of the total planned MACE were observed.
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Secondary Outcomes (4)
Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)
Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up
Study Arms (2)
NB32
EXPERIMENTALPBO
PLACEBO COMPARATORInterventions
Naltrexone SR 32 mg/Bupropion SR 360 mg/day. 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.
Eligibility Criteria
You may qualify if:
- ≥50 years of age (women) or ≥45 years of age (men)
- Body mass index (BMI) ≥27 kg/m2 and ≤50 kg/m2
- Waist circumference ≥88 cm (women) or ≥102 cm (men)
- 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
- +2 more criteria
You may not qualify if:
- Myocardial infarction within 3 months prior to screening
- Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
- Clinical history of cerebrovascular disease (stroke)
- History of tachyarrhythmia other than sinus tachycardia
- Planned bariatric surgery, cardiac surgery, or coronary angioplasty
- History of seizures (including febrile seizures), cranial trauma, or other conditions that predispose the subject to seizures
- Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (224)
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Mobile, Alabama, United States
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Scottsboro, Alabama, United States
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Chandler, Arizona, United States
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Mesa, Arizona, United States
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Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Tuscson, Arizona, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Escondido, California, United States
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Fresno, California, United States
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Harbor City, California, United States
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Huntington Beach, California, United States
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La Jolla, California, United States
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Lomita, California, United States
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Los Angeles, California, United States
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Paramount, California, United States
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Pasadena, California, United States
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Riverside, California, United States
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Sacramento, California, United States
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Santa Rosa, California, United States
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Spring Valley, California, United States
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Thousand Oaks, California, United States
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Torrance, California, United States
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West Hills, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Golden, Colorado, United States
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Wheat Ridge, Colorado, United States
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Norwalk, Connecticut, United States
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Stamford, Connecticut, United States
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Wilmington, Delaware, United States
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Washington D.C., District of Columbia, United States
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Boynton Beach, Florida, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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DeLand, Florida, United States
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Delray Beach, Florida, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville Beach, Florida, United States
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Melbourne, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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New Smyrna Beach, Florida, United States
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Oakland Park, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Pinellas Park, Florida, United States
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St. Petersburg, Florida, United States
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Vero Beach, Florida, United States
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Wellington, Florida, United States
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Winter Haven, Florida, United States
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Atlanta, Georgia, United States
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Austell, Georgia, United States
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Columbus, Georgia, United States
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Lawrenceville, Georgia, United States
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Riverdale, Georgia, United States
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Savannah, Georgia, United States
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Stockbridge, Georgia, United States
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Honolulu, Hawaii, United States
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Meridian, Idaho, United States
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Chicago, Illinois, United States
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Gurnee, Illinois, United States
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Melrose Park, Illinois, United States
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Bloomington, Indiana, United States
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Brownsburg, Indiana, United States
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Elwood, Indiana, United States
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Evansville, Indiana, United States
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Hammond, Indiana, United States
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South Bend, Indiana, United States
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Valparaiso, Indiana, United States
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Ames, Iowa, United States
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Council Bluffs, Iowa, United States
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Des Moines, Iowa, United States
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West Des Moines, Iowa, United States
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Overland Park, Kansas, United States
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Wichita, Kansas, United States
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Crestview Hills, Kentucky, United States
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Louisville, Kentucky, United States
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Mount Sterling, Kentucky, United States
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Alexandria, Louisiana, United States
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Baton Rouge, Louisiana, United States
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Monroe, Louisiana, United States
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Natchitoches, Louisiana, United States
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Auburn, Maine, United States
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Bangor, Maine, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Elkridge, Maryland, United States
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Lutherville, Maryland, United States
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Salisbury, Maryland, United States
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Boston, Massachusetts, United States
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Brockton, Massachusetts, United States
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Fall River, Massachusetts, United States
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Haverhill, Massachusetts, United States
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Methuen, Massachusetts, United States
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Bingham Farms, Michigan, United States
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Dearbon, Michigan, United States
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Kalamazoo, Michigan, United States
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Midland, Michigan, United States
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Saginaw, Michigan, United States
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Southfield, Michigan, United States
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Stevensville, Michigan, United States
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Edina, Minnesota, United States
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Rochester, Minnesota, United States
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Jackson, Mississippi, United States
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Olive Branch, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Butte, Montana, United States
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Missoula, Montana, United States
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Fremont, Nebraska, United States
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Grand Island, Nebraska, United States
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Omaha, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Sparks, Nevada, United States
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Belvidere, New Jersey, United States
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Edison, New Jersey, United States
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Elizabeth, New Jersey, United States
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Elmer, New Jersey, United States
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Linden, New Jersey, United States
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Ridgewood, New Jersey, United States
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Albuquerque, New Mexico, United States
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Endwell, New York, United States
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New Hyde Park, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Syracuse, New York, United States
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The Bronx, New York, United States
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Williamsville, New York, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Greensboro, North Carolina, United States
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Greenville, North Carolina, United States
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Hickory, North Carolina, United States
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Morganton, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Akron, Ohio, United States
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Beachwood, Ohio, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Delaware, Ohio, United States
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Kettering, Ohio, United States
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Marion, Ohio, United States
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Mentor, Ohio, United States
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Willoughby Hills, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Altoona, Pennsylvania, United States
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Bensalem, Pennsylvania, United States
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Danville, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Ephrata, Pennsylvania, United States
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Jersey Shore, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Lansdale, Pennsylvania, United States
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Norristown, Pennsylvania, United States
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Scottdale, Pennsylvania, United States
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Sellersville, Pennsylvania, United States
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State College, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Wilkes-Barre, Pennsylvania, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Greenville, South Carolina, United States
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Greer, South Carolina, United States
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Hodges, South Carolina, United States
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Laurens, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Rapid City, South Dakota, United States
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Bristol, Tennessee, United States
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Chattanooga, Tennessee, United States
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Germantown, Tennessee, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Beaumont, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Hurst, Texas, United States
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Lake Jackson, Texas, United States
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McKinney, Texas, United States
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San Antonio, Texas, United States
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Schertz, Texas, United States
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Tomball, Texas, United States
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Waco, Texas, United States
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Bountiful, Utah, United States
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Draper, Utah, United States
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Murray, Utah, United States
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Ogden, Utah, United States
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Orem, Utah, United States
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Salt Lake City, Utah, United States
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West Jordan, Utah, United States
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Alexandria, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Winchester, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Tacoma, Washington, United States
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Walla Walla, Washington, United States
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Green Bay, Wisconsin, United States
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Kenosha, Wisconsin, United States
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Madison, Wisconsin, United States
Related Publications (1)
Nissen SE, Wolski KE, Prcela L, Wadden T, Buse JB, Bakris G, Perez A, Smith SR. Effect of Naltrexone-Bupropion on Major Adverse Cardiovascular Events in Overweight and Obese Patients With Cardiovascular Risk Factors: A Randomized Clinical Trial. JAMA. 2016 Mar 8;315(10):990-1004. doi: 10.1001/jama.2016.1558.
PMID: 26954408DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated early. Outcome measures data is based on the 50% interim analysis, designated as the primary analysis. Safety data is based on all available data at the time of database lock, which occurred after the 50% interim analysis.
Results Point of Contact
- Title
- Global Head of Development
- Organization
- Orexigen Therapeutics, Inc.
Study Officials
- STUDY DIRECTOR
Medical Director Clinical Science
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2012
First Posted
May 18, 2012
Study Start
June 1, 2012
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
February 27, 2017
Results First Posted
February 27, 2017
Record last verified: 2016-04