Trial · NCT00456521
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
NCT00456521, Phase 3, Completed, Orexigen Therapeutics, Inc; results first posted 2014-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program. Trials, record NCT00456521. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00456521
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
- NCT number
- NCT00456521
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 793 participants, actual
- Lead sponsor
- Orexigen Therapeutics, Inc
- Conditions
- Obesity, Overweight
- Interventions
- Naltrexone SR 32 mg/ bupropion SR 360 mg/ day, Placebo, Intensive group lifestyle modification counseling
- First posted
- 2007-04-05
- Last updated
- 2014-12-17
- Results first posted
- 2014-11-21
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Co-primary: Body Weight- Mean Percent Change | Baseline, 56 weeks | |
| Primary | Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease | Baseline, 56 weeks | |
| Secondary | Body Weight- Proportion of Subjects With ≥10% Decrease | Baseline, 56 weeks | |
| Secondary | Change in Waist Circumference | Baseline, 56 weeks | |
| Secondary | Change in Fasting Triglycerides Levels, Using Log-transformed Data | Baseline, 56 weeks | |
| Secondary | Change in Fasting Insulin Levels, Using Log-transformed Data | Baseline, 56 weeks | |
| Secondary | Change in Fasting HDL Cholesterol Levels | Baseline, 56 weeks | |
| Secondary | Change in IWQOL-Lite Total Scores | Baseline, 56 weeks | IWQOL-Lite= Impact of Weight on Quality of Life-Lite Questionnaire Total score is based on a scale from 0 to 100, with 0 representing the poorest and 100 the best quality of life and where a score of 71-79 indicates moderate impairment |
| Secondary | Change in HOMA-IR Levels, Using Log-transformed Data | Baseline, 56 weeks | HOMA-IR= Homeostasis Model Assessment-Insulin Resistance |
| Secondary | Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data | Baseline, 56 weeks |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Co-primary: Body Weight- Mean Percent Change | Baseline, 56 weeks | Modified ITT (Full Analysis Set): Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percentage of body weight | LEAST_SQUARES_MEAN |
| PRIMARY | Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Body Weight- Proportion of Subjects With ≥10% Decrease | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percentage of participants | NUMBER |
| SECONDARY | Change in Waist Circumference | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | cm | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Triglycerides Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting Insulin Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Fasting HDL Cholesterol Levels | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | mg/dL | LEAST_SQUARES_MEAN |
| SECONDARY | Change in IWQOL-Lite Total Scores | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change in HOMA-IR Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data | Baseline, 56 weeks | Modified ITT: Included all subjects who were randomized, had a baseline weight measurement, and had at least one post-baseline weight measurement while on study drug. Missing data were imputed with the LOCF method. | percent change | LEAST_SQUARES_MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Co-primary: Body Weight- Mean Percent Change | NB32 | -9.29 | Standard Error 0.40 | percentage of body weight | |
| Co-primary: Body Weight- Mean Percent Change | Placebo | -5.08 | Standard Error 0.60 | percentage of body weight | |
| Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease | NB32 | 66.39 | 95% Confidence Interval 62.17 to 70.61 | percentage of participants | |
| Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease | Placebo | 42.49 | 95% Confidence Interval 35.51 to 49.46 | percentage of participants | |
| Body Weight- Proportion of Subjects With ≥10% Decrease | NB32 | 41.49 | 95% Confidence Interval 37.10 to 45.89 | percentage of participants | |
| Body Weight- Proportion of Subjects With ≥10% Decrease | Placebo | 20.21 | 95% Confidence Interval 14.54 to 25.87 | percentage of participants | |
| Change in Waist Circumference | NB32 | -9.98 | Standard Error 0.48 | cm | |
| Change in Waist Circumference | Placebo | -6.77 | Standard Error 0.75 | cm | |
| Change in Fasting Triglycerides Levels, Using Log-transformed Data | NB32 | -16.62 | 95% Confidence Interval -19.66 to -13.47 | percent change | |
| Change in Fasting Triglycerides Levels, Using Log-transformed Data | Placebo | -8.51 | 95% Confidence Interval -13.67 to -3.03 | percent change |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NB32 | 591 | |
| Overall Study | STARTED | Placebo | 202 | |
| Overall Study | COMPLETED | NB32 | 342 | |
| Overall Study | COMPLETED | Placebo | 118 | |
| Overall Study | NOT COMPLETED | NB32 | 249 | |
| Overall Study | NOT COMPLETED | Placebo | 84 |
Source ClinicalTrials.gov
Adverse events92
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 | Tinnitus | Ear and labyrinth disorders | NB32 | 31 | 584 | 33 |
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 1 | 200 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | NB32 | 32 | 584 | 33 |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 3 | 200 | 4 |
| other | Constipation | Gastrointestinal disorders | NB32 | 141 | 584 | 157 |
| other | Constipation | Gastrointestinal disorders | Placebo | 28 | 200 | 32 |
| other | Diarrhoea | Gastrointestinal disorders | NB32 | 43 | 584 | 45 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 15 | 200 | 16 |
| other | Dry mouth | Gastrointestinal disorders | NB32 | 47 | 584 | 48 |
| other | Dry mouth | Gastrointestinal disorders | Placebo | 6 | 200 | 6 |
1 to 10 of 92Source ClinicalTrials.gov
See all 92 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 | 465 | 584 |
| Total, other adverse events | Placebo | 132 | 200 |
| Total, serious adverse events | NB32 | 22 | 584 |
| Total, serious adverse events | Placebo | 1 | 200 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20559296 | RESULT |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| NB32 vs Placebo: serious adverse events |
Source 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/NCT00456521
GET https://conductscience.org/api/trials/v1/NCT00456521/results?page=2