Trial · NCT01601704
Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
NCT01601704, Phase 3, Terminated, Orexigen Therapeutics, Inc; results first posted 2017-02-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study). Trials, record NCT01601704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01601704
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cardiovascular Outcomes Study of Naltrexone SR/Bupropion SR in Overweight and Obese Subjects With Cardiovascular Risk Factors (The Light Study)
- NCT number
- NCT01601704
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 8,910 participants, actual
- Lead sponsor
- Orexigen Therapeutics, Inc
- Conditions
- Obesity, Overweight
- Interventions
- NB32, PBO, Weight Management Program
- First posted
- 2012-05-18
- Last updated
- 2017-02-27
- Results first posted
- 2017-02-27
- 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.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) | Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up | 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. |
| Secondary | 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 | Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. |
| Secondary | 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 | Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. |
| Secondary | 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 | Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. |
| Secondary | 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 | Due to early termination of the study, the pre-planned 50% interim analysis is considered the primary analysis for outcome measures. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) | Confirmed occurrence of event between Day 1 (randomization) and up to a maximum of 4 years of follow-up | Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | Intent-to-treat (ITT) population is defined as subjects who undergo randomization into the Treatment Period (TP) and are dispensed study medication. Treatment refers to the treatment assigned during TP randomization rather than the actual treatment received. ITT population is the primary analysis population for the primary and secondary endpoints. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) | NB32 | 90 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) | Placebo | 102 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization | NB32 | 133 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization | Placebo | 142 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke) | NB32 | 17 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke) | Placebo | 34 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal) | NB32 | 55 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal) | Placebo | 57 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal) | NB32 | 22 | Participants | ||
| Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal) | Placebo | 21 | Participants |
Source ClinicalTrials.gov
Participant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NB32 | 4,456 | |
| Overall Study | STARTED | Placebo | 4,454 | |
| Overall Study | Treated | NB32 | 4,455 | |
| Overall Study | Treated | Placebo | 4,450 | |
| Overall Study | COMPLETED | NB32 | 4,455 | |
| Overall Study | COMPLETED | Placebo | 4,450 | |
| Overall Study | NOT COMPLETED | NB32 | 1 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events1,268
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Angina pectoris | Cardiac disorders | NB32 | 4 | 4,455 | 4 |
| other | Angina pectoris | Cardiac disorders | Placebo | 1 | 4,450 | 1 |
| other | Atrial fibrillation | Cardiac disorders | NB32 | 0 | 4,455 | 0 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 1 | 4,450 | 1 |
| other | Bradycardia | Cardiac disorders | NB32 | 3 | 4,455 | 3 |
| other | Bradycardia | Cardiac disorders | Placebo | 0 | 4,450 | 0 |
| other | Cardiac discomfort | Cardiac disorders | NB32 | 1 | 4,455 | 1 |
| other | Cardiac discomfort | Cardiac disorders | Placebo | 0 | 4,450 | 0 |
| other | Cardiac failure congestive | Cardiac disorders | NB32 | 1 | 4,455 | 1 |
| other | Cardiac failure congestive | Cardiac disorders | Placebo | 0 | 4,450 | 0 |
1 to 10 of 1,268Source ClinicalTrials.gov
See all 1,268 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NB32 | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | NB32 | 1,157 | 4,455 |
| Total, other adverse events | Placebo | 282 | 4,450 |
| Total, serious adverse events | NB32 | 463 | 4,455 |
| Total, serious adverse events | Placebo | 386 | 4,450 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26954408 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| NB32 vs Placebo: Percentage of Participants With a Confirmed Occurrence of Myocardial Infarction (Nonfatal or Fatal) | Trial comparisons |
| NB32 vs Placebo: Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death (Including Fatal Myocardial Infarction, Fatal Stroke) | Trial comparisons |
| NB32 vs Placebo: Percentage of Participants With a Confirmed Occurrence of Major Adverse Cardiovascular Event (MACE) | Trial comparisons |
| NB32 vs Placebo: Percentage of Participants With a Confirmed Occurrence of Stroke (Nonfatal or Fatal) | Trial comparisons |
| NB32 vs Placebo: Percentage of Participants With a Confirmed Occurrence of Cardiovascular Death, Nonfatal Myocardial Infarction, Nonfatal Stroke, or Nonfatal Unstable Angina Requiring Hospitalization | Trial comparisons |
| NB32 vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01601704
GET https://conductscience.org/api/trials/v1/NCT01601704/events?page=2