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ObesityPhase 3NCT01601704

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

A Phase 3 study testing NB32, PBO and Weight Management Program in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 224 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
NB32, PBO and Weight Management Program
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
8,910 participants
Where
224 sitesUnited States
Study dates
Jun 2012to Aug 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥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
Show all 17Show fewer
  • 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

Who cannot join

  • 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
  • History of mania or current diagnosis of active psychosis, active bulimia or anorexia nervosa (binge eating disorder is not exclusionary)
  • Any condition with life expectancy anticipated to be less than 4 years (e.g., congestive heart failure NYHA Class 3 or 4)

Trial locations and contacts

224 sites in 1 country.

224 sites in 1 country

United States224 sites

  • Study site

    Akron, Ohio

  • Study site

    Albuquerque, New Mexico

  • Study site

    Alexandria, Louisiana

  • Study site

    Alexandria, Virginia

  • Study site

    Altoona, Pennsylvania

  • Study site

    Ames, Iowa

  • Study site

    Anaheim, California

  • Study site

    Anderson, South Carolina

  • Study site

    Atlanta, Georgia

  • Study site

    Auburn, Maine

  • Study site

    Austell, Georgia

  • Study site

    Baltimore, Maryland

  • Study site

    Bangor, Maine

  • Study site

    Baton Rouge, Louisiana

  • Study site

    Beachwood, Ohio

  • Study site

    Beaumont, Texas

  • Study site

    Belvidere, New Jersey

  • Study site

    Bensalem, Pennsylvania

  • Study site

    Bingham Farms, Michigan

  • Study site

    Birmingham, Alabama

  • Study site

    Bloomington, Indiana

  • Study site

    Boston, Massachusetts

  • Study site

    Bountiful, Utah

  • Study site

    Boynton Beach, Florida

  • Study site

    Bristol, Tennessee

  • Study site

    Brockton, Massachusetts

  • Study site

    Brooksville, Florida

  • Study site

    Brownsburg, Indiana

  • Study site

    Butte, Montana

  • Study site

    Carmichael, California

  • Study site

    Cary, North Carolina

  • Study site

    Chandler, Arizona

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Chattanooga, Tennessee

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Columbia, Maryland

  • Study site

    Columbia, South Carolina

  • Study site

    Columbus, Georgia

  • Study site

    Columbus, Ohio

  • Study site

    Corpus Christi, Texas

  • Study site

    Council Bluffs, Iowa

  • Study site

    Crestview Hills, Kentucky

  • Study site

    Dallas, Texas

  • Study site

    Danville, Pennsylvania

  • Study site

    Dearbon, Michigan

  • Study site

    DeLand, Florida

  • Study site

    Delaware, Ohio

  • Study site

    Delray Beach, Florida

  • Study site

    Denver, Colorado

  • Study site

    Des Moines, Iowa

  • Study site

    Dothan, Alabama

  • Study site

    Draper, Utah

  • Study site

    Duncansville, Pennsylvania

  • Study site

    Durham, North Carolina

  • Study site

    Edina, Minnesota

  • Study site

    Edison, New Jersey

  • Study site

    Elizabeth, New Jersey

  • Study site

    Elizabeth City, North Carolina

  • Study site

    Elkridge, Maryland

  • Study site

    Elmer, New Jersey

  • Study site

    Elwood, Indiana

  • Study site

    Endwell, New York

  • Study site

    Ephrata, Pennsylvania

  • Study site

    Escondido, California

  • Study site

    Evansville, Indiana

  • Study site

    Fall River, Massachusetts

  • Study site

    Fremont, Nebraska

  • Study site

    Fresno, California

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee

  • Study site

    Golden, Colorado

  • Study site

    Grand Island, Nebraska

  • Study site

    Green Bay, Wisconsin

  • Study site

    Greensboro, North Carolina

  • Study site

    Greenville, North Carolina

  • Study site

    Greenville, South Carolina

  • Study site

    Greer, South Carolina

  • Study site

    Gurnee, Illinois

  • Study site

    Hammond, Indiana

  • Study site

    Harbor City, California

  • Study site

    Haverhill, Massachusetts

  • Study site

    Henderson, Nevada

  • Study site

    Hickory, North Carolina

  • Study site

    Hodges, South Carolina

  • Study site

    Honolulu, Hawaii

  • Study site

    Houston, Texas

  • Study site

    Huntington Beach, California

  • Study site

    Hurst, Texas

  • Study site

    Jackson, Mississippi

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jacksonville Beach, Florida

  • Study site

    Jersey Shore, Pennsylvania

  • Study site

    Kalamazoo, Michigan

  • Study site

    Kenosha, Wisconsin

  • Study site

    Kettering, Ohio

  • Study site

    Kingsport, Tennessee

  • Study site

    Knoxville, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Lake Jackson, Texas

  • Study site

    Lancaster, Pennsylvania

  • Study site

    Lansdale, Pennsylvania

  • Study site

    Las Vegas, Nevada

  • Study site

    Laurens, South Carolina

  • Study site

    Lawrenceville, Georgia

  • Study site

    Linden, New Jersey

  • Study site

    Little Rock, Arkansas

  • Study site

    Lomita, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    Lutherville, Maryland

  • Study site

    Madison, Wisconsin

  • Study site

    Marion, Ohio

  • Study site

    McKinney, Texas

  • Study site

    Medford, Oregon

  • Study site

    Melbourne, Florida

  • Study site

    Melrose Park, Illinois

  • Study site

    Memphis, Tennessee

  • Study site

    Mentor, Ohio

  • Study site

    Meridian, Idaho

  • Study site

    Mesa, Arizona

  • Study site

    Methuen, Massachusetts

  • Study site

    Miami, Florida

  • Study site

    Midland, Michigan

  • Study site

    Missoula, Montana

  • Study site

    Mobile, Alabama

  • Study site

    Monroe, Louisiana

  • Study site

    Morganton, North Carolina

  • Study site

    Mount Sterling, Kentucky

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    Murray, Utah

  • Study site

    Natchitoches, Louisiana

  • Study site

    New Hyde Park, New York

  • Study site

    New Port Richey, Florida

  • Study site

    New Smyrna Beach, Florida

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Norristown, Pennsylvania

  • Study site

    Norwalk, Connecticut

  • Study site

    Oakland Park, Florida

  • Study site

    Ogden, Utah

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Olive Branch, Mississippi

  • Study site

    Omaha, Nebraska

  • Study site

    Orem, Utah

  • Study site

    Orlando, Florida

  • Study site

    Overland Park, Kansas

  • Study site

    Palm Harbor, Florida

  • Study site

    Paramount, California

  • Study site

    Pasadena, California

  • Study site

    Pembroke Pines, Florida

  • Study site

    Pensacola, Florida

  • Study site

    Peoria, Arizona

  • Study site

    Phoenix, Arizona

  • Study site

    Pinellas Park, Florida

  • Study site

    Portland, Oregon

  • Study site

    Raleigh, North Carolina

  • Study site

    Rapid City, South Dakota

  • Study site

    Reno, Nevada

  • Study site

    Richmond, Virginia

  • Study site

    Ridgewood, New Jersey

  • Study site

    Riverdale, Georgia

  • Study site

    Riverside, California

  • Study site

    Rochester, Minnesota

  • Study site

    Sacramento, California

  • Study site

    Saginaw, Michigan

  • Study site

    Salisbury, Maryland

  • Study site

    Salisbury, North Carolina

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Santa Rosa, California

  • Study site

    Savannah, Georgia

  • Study site

    Schertz, Texas

  • Study site

    Scottdale, Pennsylvania

  • Study site

    Scottsboro, Alabama

  • Study site

    Scottsdale, Arizona

  • Study site

    Seattle, Washington

  • Study site

    Sellersville, Pennsylvania

  • Study site

    South Bend, Indiana

  • Study site

    Southfield, Michigan

  • Study site

    Sparks, Nevada

  • Study site

    Spokane, Washington

  • Study site

    Spring Valley, California

  • Study site

    St Louis, Missouri

  • Study site

    St. Petersburg, Florida

  • Study site

    Stamford, Connecticut

  • Study site

    State College, Pennsylvania

  • Study site

    Staten Island, New York

  • Study site

    Stevensville, Michigan

  • Study site

    Stockbridge, Georgia

  • Study site

    Syracuse, New York

  • Study site

    Tacoma, Washington

  • Study site

    The Bronx, New York

  • Study site

    Thousand Oaks, California

  • Study site

    Tomball, Texas

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Tupelo, Mississippi

  • Study site

    Tuscson, Arizona

  • Study site

    Valparaiso, Indiana

  • Study site

    Vero Beach, Florida

  • Study site

    Waco, Texas

  • Study site

    Walla Walla, Washington

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Wellington, Florida

  • Study site

    West Des Moines, Iowa

  • Study site

    West Hills, California

  • Study site

    West Jordan, Utah

  • Study site

    West Reading, Pennsylvania

  • Study site

    Wheat Ridge, Colorado

  • Study site

    Wichita, Kansas

  • Study site

    Wilkes-Barre, Pennsylvania

  • Study site

    Williamsville, New York

  • Study site

    Willoughby Hills, Ohio

  • Study site

    Wilmington, Delaware

  • Study site

    Wilmington, North Carolina

  • Study site

    Winchester, Virginia

  • Study site

    Winston-Salem, North Carolina

  • Study site

    Winter Haven, Florida

Other trials in United States

About this study

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

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.

Conditions
Obesity, Overweight
Being tested
NB32, PBO, Weight Management Program
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
Medical subject headings
Obesity, Overweight, Body Weight, Cardiovascular Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2, Endocrine System Diseases, Glucose Metabolism Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NB32Drug

    Also called CONTRAVE

    Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.

  • PBODrug

    Placebo. Administered in addition to the weight management program.

  • Weight Management ProgramBehavioural

    Also called WeightMate (Tm)

    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.

Study groups in NCT01601704
Study groupRoleWhat they receive
NB32ExperimentalNot described
Receives: Drug: NB32; Behavioral: Weight Management Program
PBOPlacebo comparatorNot described
Receives: Drug: PBO; Behavioral: Weight Management Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

Secondary outcomes (4)

  1. Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization

    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.

    Measured: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

  2. Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)

    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.

    Measured: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

  3. Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)

    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.

    Measured: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

  4. Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)

    Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures.

    Measured: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
8,910 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01601704
Sponsor's protocol ID
NB-CVOT
Other IDs
The Light Study, U1111-1162-4981
Status last verified
Apr 2016
First submitted
14 May 2012
Last updated
27 Feb 2017
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26954408

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NB32, PBO and Weight Management Program in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 224 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 224 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) (time frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01601704, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2017.

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