This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT01601704
First received: May 14, 2012
Last updated: February 24, 2017
Last verified: April 2016
Results First Received: December 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Overweight
Interventions: Drug: NB32
Drug: PBO
Behavioral: Weight Management Program

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
NB32

NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.

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.

Placebo

Administered in addition to the weight management program.

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.


Participant Flow:   Overall Study
    NB32   Placebo
STARTED [1]   4456   4454 
Treated [2]   4455   4450 
COMPLETED [3]   4455   4450 
NOT COMPLETED   1   4 
Randomized but not dispensed study med                1                4 
[1] Represents number of participants randomized
[2] Represents number of participants included in the ITT analysis
[3] Completed indicates treated participants. Represents number of participants in the ITT analysis.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
NB32

NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.

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.

Placebo

Administered in addition to the weight management program.

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.

Total Total of all reporting groups

Baseline Measures
   NB32   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
Age 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2973  66.7%      3053  68.6%      6026  67.7% 
>=65 years      1482  33.3%      1397  31.4%      2879  32.3% 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
   61.1  (7.27)   60.9  (7.38)   61.0  (7.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
Female      2437  54.7%      2419  54.4%      4856  54.5% 
Male      2018  45.3%      2031  45.6%      4049  45.5% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
Hispanic or Latino      279   6.3%      291   6.5%      570   6.4% 
Not Hispanic or Latino      4174  93.7%      4156  93.4%      8330  93.5% 
Unknown or Not Reported      2   0.0%      3   0.1%      5   0.1% 
Race (NIH/OMB) [1] [2] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
American Indian or Alaska Native      11   0.2%      20   0.4%      31   0.3% 
Asian      19   0.4%      27   0.6%      46   0.5% 
Native Hawaiian or Other Pacific Islander      6   0.1%      6   0.1%      12   0.1% 
Black or African American      656  14.7%      648  14.6%      1304  14.6% 
White      3738  83.9%      3698  83.1%      7436  83.5% 
More than one race   NA [1]   NA [1]   NA [2] 
Unknown or Not Reported      25   0.6%      51   1.1%      76   0.9% 
[1] Selection of multiple race categories was not permissible by the participants. Participants advised to select the most appropriate category.
[2] Total not calculated because data are not available (NA) in one or more arms.
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
United States   4455   4450   8905 
Weight 
[Units: Kilogram]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
   105.6  (19.09)   106.3  (19.18)   106.0  (19.14) 
Body Mass Index (BMI) [1] 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 4452   4450   8902 
   37.2  (5.26)   37.4  (5.44)   37.3  (5.35) 
[1] BMI was calculated at the site. Data are missing for 3 participants for whom the site did not calculate BMI, although weight and height were measured.
Cardiovascular (CV) risk group 
[Units: Participants]
Count of Participants
     
CV disease without T2DM (type 2 diabetes mellitus)       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
CV disease without T2DM (type 2 diabetes mellitus)   670   646   1316 
CV disease with T2DM       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
CV disease with T2DM   745   801   1546 
T2DM without CV disease       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
T2DM without CV disease   3039   3002   6041 
Hypertension 
[Units: Participants]
Count of Participants
     
Yes       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
Yes   4162   4117   8279 
No       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
No   293   333   626 
Dyslipidemia 
[Units: Participants]
Count of Participants
     
Yes       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
Yes   4100   4070   8170 
No       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
No   355   380   735 
History of Depression 
[Units: Participants]
Count of Participants
     
Yes       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
Yes   1031   995   2026 
No       
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
No   3424   3455   6879 
Baseline Antidepressant Medication Use 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 4455   4450   8905 
   1042   1015   2057 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization   [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

3.  Secondary:   Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke)   [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

4.  Secondary:   Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal)   [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]

5.  Secondary:   Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal)   [ Time Frame: Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Head of Development
Organization: Orexigen Therapeutics, Inc.
phone: 858-875-8600
e-mail: MedInfo@Orexigen.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT01601704     History of Changes
Other Study ID Numbers: NB-CVOT
The Light Study ( Other Identifier: Takeda )
U1111-1162-4981 ( Registry Identifier: WHO )
Study First Received: May 14, 2012
Results First Received: December 11, 2016
Last Updated: February 24, 2017