Trial Outcomes & Findings for A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects (NCT NCT00532779)

NCT ID: NCT00532779

Last Updated: 2014-11-21

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1742 participants

Primary outcome timeframe

Baseline, 56 weeks

Results posted on

2014-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	NB16 Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo Placebo
Overall Study STARTED	578	583	581
Overall Study COMPLETED	284	296	290
Overall Study NOT COMPLETED	294	287	291

Reasons for withdrawal

Reasons for withdrawal
Measure	NB16 Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo Placebo
Overall Study Adverse Event	122	112	56
Overall Study Lost to Follow-up	76	65	66
Overall Study Withdrawal by Subject	63	60	90
Overall Study Lack of Efficacy	12	12	40
Overall Study Protocol Violation	5	9	7
Overall Study Pregnancy	2	5	3
Overall Study Death	0	1	0
Overall Study Drug noncompliance, moved, other	14	23	29

Baseline Characteristics

A Study of the Safety and Efficacy of Two Doses of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NB16 n=578 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=583 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=581 Participants Placebo	Total n=1742 Participants Total of all reporting groups
Age, Continuous	44.35 years STANDARD_DEVIATION 11.25 • n=5 Participants	44.41 years STANDARD_DEVIATION 11.14 • n=7 Participants	43.66 years STANDARD_DEVIATION 11.14 • n=5 Participants	44.14 years STANDARD_DEVIATION 11.17 • n=4 Participants
Sex: Female, Male Female	490 Participants n=5 Participants	496 Participants n=7 Participants	496 Participants n=5 Participants	1482 Participants n=4 Participants
Sex: Female, Male Male	88 Participants n=5 Participants	87 Participants n=7 Participants	85 Participants n=5 Participants	260 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	13 participants n=5 Participants	18 participants n=7 Participants	17 participants n=5 Participants	48 participants n=4 Participants
Race/Ethnicity, Customized Asian	4 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	14 participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	6 participants n=5 Participants	5 participants n=7 Participants	4 participants n=5 Participants	15 participants n=4 Participants
Race/Ethnicity, Customized Black or African American	122 participants n=5 Participants	106 participants n=7 Participants	110 participants n=5 Participants	338 participants n=4 Participants
Race/Ethnicity, Customized White	427 participants n=5 Participants	440 participants n=7 Participants	440 participants n=5 Participants	1307 participants n=4 Participants
Race/Ethnicity, Customized Other	6 participants n=5 Participants	8 participants n=7 Participants	6 participants n=5 Participants	20 participants n=4 Participants
Weight	99.49 kg STANDARD_DEVIATION 14.76 • n=5 Participants	99.70 kg STANDARD_DEVIATION 15.88 • n=7 Participants	99.45 kg STANDARD_DEVIATION 14.31 • n=5 Participants	99.55 kg STANDARD_DEVIATION 14.99 • n=4 Participants
BMI	36.22 kg/m^2 STANDARD_DEVIATION 4.28 • n=5 Participants	36.10 kg/m^2 STANDARD_DEVIATION 4.35 • n=7 Participants	36.18 kg/m^2 STANDARD_DEVIATION 4.00 • n=5 Participants	36.17 kg/m^2 STANDARD_DEVIATION 4.21 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline, 56 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	NB16 n=471 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=471 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=511 Participants Placebo
Co-primary: Body Weight- Mean Percent Change	-5.00 percentage of body weight Standard Error 0.31	-6.14 percentage of body weight Standard Error 0.31	-1.33 percentage of body weight Standard Error 0.30

PRIMARY outcome

Timeframe: Baseline, 56 weeks

Population: 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.

Outcome measures

Outcome measures
Measure	NB16 n=471 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=471 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=511 Participants Placebo
Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease	39.49 percentage of participants Interval 35.08 to 43.91	47.98 percentage of participants Interval 43.47 to 52.49	16.44 percentage of participants Interval 13.22 to 19.65

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=471 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=471 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=511 Participants Placebo
Body Weight- Proportion of Subjects With ≥10% Decrease	20.17 Percentage of participants Interval 16.55 to 23.79	24.63 Percentage of participants Interval 20.74 to 28.52	7.44 Percentage of participants Interval 5.16 to 9.71

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=342 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=356 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=348 Participants Placebo
Change in Waist Circumference	-5.04 cm Standard Error 0.43	-6.24 cm Standard Error 0.42	-2.46 cm Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=333 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=359 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=345 Participants Placebo
Change in Fasting HDL Cholesterol Levels	3.36 mg/dL Standard Error 0.47	3.42 mg/dL Standard Error 0.45	-0.06 mg/dL Standard Error 0.47

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=333 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=359 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=345 Participants Placebo
Change in Fasting Triglycerides Levels, Using Log-transformed Data	-7.96 percent change Interval -11.35 to -4.44	-12.69 percent change Interval -15.79 to -9.47	-3.08 percent change Interval -6.62 to 0.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	NB16 n=422 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=417 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=468 Participants Placebo
Change in IWQOL-Lite Total Scores	11.68 units on a scale Standard Error 0.54	12.69 units on a scale Standard Error 0.54	8.55 units on a scale Standard Error 0.51

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=331 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=353 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=340 Participants Placebo
Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data	-28.02 percent change Interval -34.09 to -21.39	-28.98 percent change Interval -34.79 to -22.65	-16.66 percent change Interval -23.68 to -9.0

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=309 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=344 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=326 Participants Placebo
Change in Fasting Insulin Levels, Using Log-transformed Data	-11.84 percent change Interval -17.28 to -6.05	-17.14 percent change Interval -21.96 to -12.02	-4.57 percent change Interval -10.35 to 1.58

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=336 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=361 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=348 Participants Placebo
Change in Fasting Blood Glucose Levels	-2.39 mg/dL Standard Error 0.57	-3.24 mg/dL Standard Error 0.55	-1.30 mg/dL Standard Error 0.56

SECONDARY outcome

Timeframe: Baseline, 56 weeks

HOMA-IR= Homeostasis Model Assessment-Insulin Resistance

Outcome measures

Outcome measures
Measure	NB16 n=305 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=341 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=325 Participants Placebo
Change in HOMA-IR Levels, Using Log-transformed Data	-14.33 percent change Interval -20.13 to -8.1	-20.19 percent change Interval -25.26 to -14.78	-5.90 percent change Interval -12.11 to 0.74

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult

Outcome measures

Outcome measures
Measure	NB16 n=410 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=409 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=453 Participants Placebo
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire	-12.49 units on a scale Standard Error 1.10	-14.52 units on a scale Standard Error 1.09	-8.68 units on a scale Standard Error 1.04

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=332 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=358 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=345 Participants Placebo
Change in Fasting LDL Cholesterol Levels	-3.67 mg/dL Standard Error 1.21	-4.41 mg/dL Standard Error 1.17	-3.28 mg/dL Standard Error 1.20

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=471 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=471 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=511 Participants Placebo
Change in Systolic Blood Pressure	0.29 mm Hg Standard Error 0.40	-0.11 mm Hg Standard Error 0.41	-1.94 mm Hg Standard Error 0.39

SECONDARY outcome

Timeframe: Baseline, 56 weeks

Outcome measures

Outcome measures
Measure	NB16 n=471 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=471 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=511 Participants Placebo
Change in Diastolic Blood Pressure	0.09 mm Hg Standard Error 0.29	0.04 mm Hg Standard Error 0.29	-0.86 mm Hg Standard Error 0.28

SECONDARY outcome

Timeframe: Baseline, 56 weeks

IDS-SR= Inventory of Depressive Symptoms-Subject Rated IDS-SR total score is based on 30 items. The total score can range from 0-84, with 0 being no depressive symptoms and 84 being very severe depressive symptoms. A total score ≤ 13 indicates no depression.

Outcome measures

Outcome measures
Measure	NB16 n=471 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=470 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=511 Participants Placebo
Change in IDS-SR Total Scores	0.02 units on a scale Standard Error 0.21	-0.27 units on a scale Standard Error 0.21	-0.72 units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, 56 weeks

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The sweets subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).

Outcome measures

Outcome measures
Measure	NB16 n=423 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=418 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=470 Participants Placebo
Change in Food Craving Inventory Sweets Subscale Score	-2.08 units on a scale Standard Error 0.21	-2.62 units on a scale Standard Error 0.21	-2.77 units on a scale Standard Error 0.20

SECONDARY outcome

Timeframe: Baseline, 56 weeks

The Food Craving Inventory is a 33-item self-report measure designed to assess specific food cravings and is organized into 4 subscales (high fats, sweets, carbohydrates/starches, and fast-food fats). A craving was defined as an intense desire to consume a particular food (or food type) that was difficult to resist over the past month. Subjects rated their frequency of cravings for each of the 33 items using a 5-point scale, where 1=never, 2=rarely, 3=sometimes, 4=often, and 5=always. The carbohydrates subscale consisted of 8 items and the score ranges from 8 (better outcome) to 40 (worse outcome).

Outcome measures

Outcome measures
Measure	NB16 n=423 Participants Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=418 Participants Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=469 Participants Placebo
Change in Food Craving Inventory Carbohydrates Subscale Score	-1.85 units on a scale Standard Error 0.20	-2.11 units on a scale Standard Error 0.20	-1.84 units on a scale Standard Error 0.19

Adverse Events

NB16

Serious events: 9 serious events

Other events: 345 other events

Deaths: 0 deaths

NB32

Serious events: 9 serious events

Other events: 365 other events

Deaths: 0 deaths

Placebo

Serious events: 8 serious events

Other events: 230 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	NB16 n=569 participants at risk Naltrexone SR 16 mg/Bupropion SR 360 mg /day	NB32 n=573 participants at risk Naltrexone SR 32 mg/Bupropion SR 360 mg /day	Placebo n=569 participants at risk Placebo
Gastrointestinal disorders Constipation	15.8% 90/569 • Number of events 99 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	15.7% 90/573 • Number of events 98 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	5.6% 32/569 • Number of events 36 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Gastrointestinal disorders Diarrhoea	5.4% 31/569 • Number of events 38 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	4.5% 26/573 • Number of events 28 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	4.9% 28/569 • Number of events 33 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Gastrointestinal disorders Dry mouth	7.4% 42/569 • Number of events 44 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	7.5% 43/573 • Number of events 44 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	1.9% 11/569 • Number of events 12 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Gastrointestinal disorders Nausea	27.2% 155/569 • Number of events 182 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	29.8% 171/573 • Number of events 197 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	5.3% 30/569 • Number of events 32 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Gastrointestinal disorders Vomiting	6.3% 36/569 • Number of events 51 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	9.8% 56/573 • Number of events 63 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	2.5% 14/569 • Number of events 14 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Infections and infestations Nasopharyngitis	5.6% 32/569 • Number of events 40 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	5.1% 29/573 • Number of events 33 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	5.4% 31/569 • Number of events 33 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Infections and infestations Sinusitis	6.0% 34/569 • Number of events 39 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	5.2% 30/573 • Number of events 34 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	6.0% 34/569 • Number of events 39 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Infections and infestations Upper respiratory tract infection	8.6% 49/569 • Number of events 62 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	9.9% 57/573 • Number of events 77 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	11.2% 64/569 • Number of events 83 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Nervous system disorders Dizziness	7.7% 44/569 • Number of events 52 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	9.4% 54/573 • Number of events 65 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	2.6% 15/569 • Number of events 17 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Nervous system disorders Headache	16.0% 91/569 • Number of events 107 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	13.8% 79/573 • Number of events 91 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	9.3% 53/569 • Number of events 58 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Psychiatric disorders Insomnia	6.3% 36/569 • Number of events 38 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	7.5% 43/573 • Number of events 44 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	5.1% 29/569 • Number of events 30 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.
Vascular disorders Hot flush	2.3% 13/569 • Number of events 15 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	5.2% 30/573 • Number of events 33 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.	1.2% 7/569 • Number of events 7 • Baseline, 56 weeks The safety analysis set includes all randomized subjects who took study drug and were assessed by investigator after their first dose, whether or not they discontinue the study. Treatment-emergent adverse events were defined as events that started or worsened in the double-blind treatment phase after the first dose and before 7 days post last dose.

Additional Information

Senior Vice President, Head of Global Development

Orexigen Therapeutics, Inc.

Phone: (858) 875-8600

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If not already published by Sponsor as part of a multi-center publication, 18 months after conclusion of the study at all study centers, PI may publish the results for PI's study center individually. Prior to such publication, PI must provide Sponsor with at least 60 days to review and comment on the proposed publication. The review period may be extended by an additional 30 days upon request. Sponsor may delay publication for up to an additional 6 month period to file for patent protection.
Publication restrictions are in place

Restriction type: OTHER