Trial · NCT00474630

A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes

NCT00474630, 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 Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes. Trials, record NCT00474630. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00474630

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes
NCT number: NCT00474630
Status: Completed
Phases: Phase 3
Enrollment: 505 participants, actual
Lead sponsor: Orexigen Therapeutics, Inc
Conditions: Obesity, Overweight, Diabetes Mellitus, Type 2
Interventions: Naltrexone SR 32 mg/bupropion SR 360 mg/ day, Placebo, Ancillary therapy
First posted: 2007-05-17
Last updated: 2014-11-21
Results first posted: 2014-11-21

Source ClinicalTrials.gov

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame
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	Change in HbA1c Levels	Baseline, 56 weeks
Secondary	Change in Fasting Triglycerides Levels, Using Log-transformed Data	Baseline, 56 weeks
Secondary	Change in Fasting HDL Cholesterol Levels	Baseline, 56 weeks
Secondary	Change in Fasting Blood Glucose Levels	Baseline, 56 weeks
Secondary	Change in Waist Circumference	Baseline, 56 weeks
Secondary	Body Weight- Proportion of Subjects With ≥10% Decrease	Baseline, 56 weeks
Secondary	HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint	Baseline, 56 weeks
Secondary	Percent of Subjects Requiring Rescue Medications for Diabetes	Baseline, 56 weeks

1 to 10 of 25Source ClinicalTrials.gov

See all 25 registered outcomes

Outcomes25

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
SECONDARY	Change in HbA1c 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.	percent	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	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 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 Fasting Blood Glucose 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 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	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	HbA1c- Proportion of Subjects With HbA1c <7% at Endpoint	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	Percent of Subjects Requiring Rescue Medications for Diabetes	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

1 to 10 of 25Source ClinicalTrials.gov

See all 25 outcomes

Results by group50

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Co-primary: Body Weight- Mean Percent Change	NB32	-5.03	Standard Error 0.34	percentage of body weight
Co-primary: Body Weight- Mean Percent Change	Placebo	-1.75	Standard Error 0.43	percentage of body weight
Change in HbA1c Levels	NB32	-0.63	Standard Error 0.07	percent
Change in HbA1c Levels	Placebo	-0.14	Standard Error 0.09	percent
Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease	NB32	44.53	95% Confidence Interval 38.54 to 50.51	percentage of participants
Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease	Placebo	18.87	95% Confidence Interval 12.79 to 24.95	percentage of participants
Change in Fasting Triglycerides Levels, Using Log-transformed Data	NB32	-11.20	95% Confidence Interval -15.59 to -6.58	percent change
Change in Fasting Triglycerides Levels, Using Log-transformed Data	Placebo	-0.80	95% Confidence Interval -6.95 to 5.76	percent change
Change in Fasting HDL Cholesterol Levels	NB32	3.03	Standard Error 0.49	mg/dL
Change in Fasting HDL Cholesterol Levels	Placebo	-0.29	Standard Error 0.61	mg/dL

1 to 10 of 50Source ClinicalTrials.gov

See all 50 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	NB32	335
Overall Study	STARTED	Placebo	170
Overall Study	COMPLETED	NB32	175
Overall Study	COMPLETED	Placebo	100
Overall Study	NOT COMPLETED	NB32	160
Overall Study	NOT COMPLETED	Placebo	70

Source ClinicalTrials.gov

Adverse events86

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	Abdominal pain upper	Gastrointestinal disorders	NB32	17	333	18
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	3	169	4
other	Constipation	Gastrointestinal disorders	NB32	59	333	69
other	Constipation	Gastrointestinal disorders	Placebo	12	169	13
other	Diarrhoea	Gastrointestinal disorders	NB32	52	333	60
other	Diarrhoea	Gastrointestinal disorders	Placebo	16	169	21
other	Dry mouth	Gastrointestinal disorders	NB32	21	333	22
other	Dry mouth	Gastrointestinal disorders	Placebo	5	169	5
other	Nausea	Gastrointestinal disorders	NB32	141	333	196
other	Nausea	Gastrointestinal disorders	Placebo	12	169	13

1 to 10 of 86Source ClinicalTrials.gov

See all 86 adverse events

Adverse 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	275	333
Total, other adverse events	Placebo	109	169
Total, serious adverse events	NB32	13	333
Total, serious adverse events	Placebo	8	169

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
24144653	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00474630

GET https://conductscience.org/api/trials/v1/NCT00474630/registered?page=2

API reference For AI assistants