CClinicalTrials.gg
Sign In
CompletedNCT01764386Updated Dec 29, 2015Results posted

Method-of-Use Study Assessing the Effect of Naltrexone Sustained Release (SR)/ Bupropion SR on Body Weight and Cardiovascular Risk Factors in Overweight and Obese Subjects

A Phase 3 interventional study of NB and CLI in Obesity and Overweight, sponsored by Orexigen Therapeutics, Inc. Completed at 15 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2015-12-29.

Sponsored by Orexigen Therapeutics, Inc · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
242
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

The purpose of this Phase 3b study is to assess the effects of combination therapy with naltrexone SR/bupropion SR (NB) used in conjunction with a comprehensive lifestyle intervention (CLI) and in a manner consistent with its intended use after marketing approval, on body weight and cardiovascular risk factors compared to the effects of Usual Care in subjects who are overweight with dyslipidemia and/or controlled hypertension or obese. Subjects in the NB and CLI group are required to undergo an evaluation to continue treatment at Week 16. Subjects are to be discontinued from full participation if they do not lose at least 5% of their body weight relative to baseline and/or are experiencing sustained increases in blood pressure (systolic or diastolic) of ≥10 mmHg above baseline. At Week 26, subjects originally assigned to Usual Care switch to treatment with NB and CLI, and subjects assigned to NB and CLI continue treatment for the duration of the study (78-weeks treatment period).

02

Conditions studied

  • Obesity
  • Overweight

Keywords

  • obesity, overweight
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 242 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Orexigen Therapeutics, Inc is the lead sponsor of 18 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Female or male, 18 to 60 years old
  • Body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 for subjects with uncomplicated obesity, or BMI ≥27 kg/m2 and ≤45 kg/m2 for subjects with dyslipidemia and/or controlled hypertension

Exclusion criteria

Exclusion Criteria:

  • History of type 1 or type 2 diabetes mellitus diagnosis
  • Myocardial infarction within 6 months prior to screening
  • Angina pectoris Grade III or IV as per the Canadian Cardiovascular Society grading scheme
  • Clinical history of large vessel cortical strokes, including ischemic and hemorrhagic strokes (i.e., transient ischemic attack is not exclusionary)
  • History (within the last 20 years) of seizures, cranial trauma, bulimia, anorexia nervosa, or other conditions that predispose subjects to seizures
  • Past or planned surgical or device intervention (e.g., gastric banding) for obesity
  • Chronic use or positive screen for opioids
  • Regular use of tobacco products
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    NB + CLI

    Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with comprehensive lifestyle intervention (CLI)

    Drug: NB · Behavioral: CLI

  • Other
    Usual Care

    Usual Care (self-directed lifestyle intervention) Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.

    Behavioral: Usual Care

Interventions

  • DrugNB

    Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)

  • BehavioralCLI

    The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.

  • BehavioralUsual Care

    Usual Care is a self-directed lifestyle intervention program

06

What researchers measure

Primary outcomes

  1. Percent Change in Body Weight From Baseline (Day 1) to Week 26

    Time frame: Baseline to Week 26

Secondary outcomes

  1. Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26

    Time frame: Baseline to Week 26

  2. Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26

    Time frame: Baseline to Week 26

  3. Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26

    Time frame: Baseline to Week 26

  4. Absolute Change in Body Weight From Baseline to Week 26

    Time frame: Baseline to Week 26

  5. Change in Waist Circumference From Baseline to Week 26

    Time frame: Baseline to Week 26

  6. Change in Fasting Triglycerides From Baseline to Week 26

    Time frame: Baseline to Week 26

  7. Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26

    Time frame: Baseline to Week 26

  8. Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26

    Time frame: Baseline to Week 26

  9. Change in Systolic Blood Pressure From Baseline to Week 26

    Time frame: Baseline to Week 26

  10. Change in Diastolic Blood Pressure From Baseline to Week 26

    Time frame: Baseline to Week 26

  11. Change in Heart Rate From Baseline to Week 26

    Time frame: Baseline to Week 26

  12. Change in Fasting Plasma Glucose From Baseline to Week 26

    Time frame: Baseline to Week 26

  13. Change Fasting Insulin From Baseline to Week 26

    Time frame: Baseline to Week 26

  14. Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26

    HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose \* Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.

    Time frame: Baseline to Week 26

  15. Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26

    The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.

    Time frame: Baseline to Week 26

  16. Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26

    Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.

    Time frame: Baseline to Week 26

  17. Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26

    Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite 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.

    Time frame: Baseline to Week 26

07

Results

Posted Nov 26, 2015

Participant flow

Controlled Treatment Period (CTP)
Participant flow — Controlled Treatment Period (CTP)
MilestoneNB + CLIUsual Care
Started15389
Completed7182
Not completed827
Withdrew: Adverse event350
Withdrew: Wk 16 efficacy and bp criteria320
Withdrew: Lost to follow-up95
Withdrew: Withdrawal of consent,protocol deviation62
Uncontrolled Treatment Period (UTP)
Participant flow — Uncontrolled Treatment Period (UTP)
MilestoneNB + CLIUsual Care
Started7181
Completed 52 weeks6135
Completed5528
Not completed1653
Withdrew: Adverse event213
Withdrew: Wk 42 efficacy and bp criteria026
Withdrew: Lost to follow-up99
Withdrew: Withdrawal of consent,protocol deviation55

Outcome measures

PrimaryPercent Change in Body Weight From Baseline (Day 1) to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · percent change in body weight
Percent Change in Body Weight From Baseline (Day 1) to Week 26
percent change in body weightNB + CLIUsual Care
Percent Change in Body Weight From Baseline (Day 1) to Week 26-9.46 ± 0.54-0.94 ± 0.49
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = <0.0001 · Mean difference (net): -8.52 · 95% CI -9.88 to -7.15
SecondaryPercentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26
Time frame:
Baseline to Week 26
Reported as:
Number · percentage of participants
Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 26
percentage of participantsNB + CLIUsual Care
Percentage of Subjects Achieving a Loss of at Least 5% of Baseline Body Weight at Week 2684.512.2
Statistical analysis
  • NB + CLI vs Usual Care · Regression, Logistic · p = <0.0001 · Odds ratio (or): 44.0 · 95% CI 16.6 to 116.3
SecondaryPercentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26
Time frame:
Baseline to Week 26
Reported as:
Number · percentage of participants
Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 26
percentage of participantsNB + CLIUsual Care
Percentage of Subjects Achieving a Loss of at Least 10% of Baseline Body Weight at Week 2642.33.7
Statistical analysis
  • NB + CLI vs Usual Care · Regression, Logistic · p = <0.0001 · Odds ratio (or): 21.4 · 95% CI 6.0 to 76.7
SecondaryPercentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26
Time frame:
Baseline to Week 26
Reported as:
Number · percentage of participants
Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 26
percentage of participantsNB + CLIUsual Care
Percentage of Subjects Achieving a Loss of at Least 15% of Baseline Body Weight at Week 2612.70.0
SecondaryAbsolute Change in Body Weight From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · kg
Absolute Change in Body Weight From Baseline to Week 26
kgNB + CLIUsual Care
Absolute Change in Body Weight From Baseline to Week 26-9.7 ± 0.56-1.0 ± 0.51
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = <0.0001 · Mean difference (net): -8.65 · 95% CI -10.07 to -7.24
SecondaryChange in Waist Circumference From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · cm
Change in Waist Circumference From Baseline to Week 26
cmNB + CLIUsual Care
Change in Waist Circumference From Baseline to Week 26-6.96 ± 0.705-1.64 ± 0.659
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = <0.0001 · Mean difference (net): -5.32 · 95% CI -7.14 to -3.50
SecondaryChange in Fasting Triglycerides From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · mg/dL
Change in Fasting Triglycerides From Baseline to Week 26
mg/dLNB + CLIUsual Care
Change in Fasting Triglycerides From Baseline to Week 26-13.6 ± 4.962.8 ± 4.63
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.0019 · Mean difference (net): -16.4 · 95% CI -29.5 to -3.3
SecondaryChange in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · mg/dL
Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26
mg/dLNB + CLIUsual Care
Change in Fasting Low-density Lipoprotein Cholesterol From Baseline to Week 26-2.0 ± 2.20-1.9 ± 2.11
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.9686 · Mean difference (net): -0.1 · 95% CI -5.96 to 5.73
SecondaryChange in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · mg/dL
Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 26
mg/dLNB + CLIUsual Care
Change in Fasting High-density Lipoprotein Cholesterol From Baseline to Week 264.1 ± 0.770.1 ± 0.73
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.0001 · Mean difference (net): 4.0 · 95% CI 1.99 to 6.06
SecondaryChange in Systolic Blood Pressure From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · mm Hg
Change in Systolic Blood Pressure From Baseline to Week 26
mm HgNB + CLIUsual Care
Change in Systolic Blood Pressure From Baseline to Week 26-4.8 ± 1.10-2.8 ± 1.02
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.1706 · Mean difference (net): -2.0 · 95% CI -4.9 to 0.9
SecondaryChange in Diastolic Blood Pressure From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · mm Hg
Change in Diastolic Blood Pressure From Baseline to Week 26
mm HgNB + CLIUsual Care
Change in Diastolic Blood Pressure From Baseline to Week 26-1.7 ± 0.83-1.3 ± 0.77
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.7160 · Mean difference (net): -0.4 · 95% CI -2.6 to 1.8
SecondaryChange in Heart Rate From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · bpm
Change in Heart Rate From Baseline to Week 26
bpmNB + CLIUsual Care
Change in Heart Rate From Baseline to Week 261.7 ± 0.88-0.3 ± 0.82
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.0913 · Mean difference (net): 2.0 · 95% CI -0.3 to 4.3
SecondaryChange in Fasting Plasma Glucose From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · mg/dL
Change in Fasting Plasma Glucose From Baseline to Week 26
mg/dLNB + CLIUsual Care
Change in Fasting Plasma Glucose From Baseline to Week 26-2.9 ± 1.041.6 ± 0.96
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.0016 · Mean difference (net): -4.5 · 95% CI -7.2 to -1.7
SecondaryChange Fasting Insulin From Baseline to Week 26
Time frame:
Baseline to Week 26
Reported as:
Least squares mean · uIU/mL
Change Fasting Insulin From Baseline to Week 26
uIU/mLNB + CLIUsual Care
Change Fasting Insulin From Baseline to Week 26-7.5 ± 0.79-3.4 ± 0.76
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.0004 · Mean difference (net): -4.1 · 95% CI -6.2 to -2.0
SecondaryChange in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26

HOMA-IR is an insulin sensitivity index that is calculated as HOMA-IR = (Glucose \* Insulin) / 405, where glucose is in mass units (mg/dL) and insulin is in µIU/mL. Higher values indicate lower insulin sensitivity.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · units on a scale
Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26
units on a scaleNB + CLIUsual Care
Change in Homeostasis Model Assessment-insulin Resistance (HOMA-IR) From Baseline to Week 26-2.0 ± 0.20-0.8 ± 0.19
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = 0.0003 · Mean difference (net): -1.2 · 95% CI -1.7 to -0.7
SecondaryChange in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26

The BES is a 16-item questionnaire that identifies different levels of binge-eating severity, with total scores ranging between 0-46. BES scores were categorized as follows: None = Scores ≤17 indicated no significant binge eating, Moderate = scores from 18 to 26 (inclusive), Severe = scores ≥27 indicated severe levels of binge eating.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · units on a scale
Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26
units on a scaleNB + CLIUsual Care
Change in Patient-reported Binge Eating Scale (BES) Total Scores From Baseline to Week 26-6.8 ± 0.721.1 ± 0.67
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = <0.0001 · Mean difference (net): -7.9 · 95% CI -9.8 to -6.0
SecondaryChange in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26

Arizona Sexual Experiences (ASEX) scale is a 5-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Possible total scores range from 5 to 30, with the higher scores indicating more sexual dysfunction.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · units on a scale
Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26
units on a scaleNB + CLIUsual Care
Change in Patient-reported Arizona Sexual Experiences Scale (ASEX) Total Scores From Baseline to Week 26-2.2 ± 0.36-0.1 ± 0.34
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = <0.0001 · Mean difference (net): -2.1 · 95% CI -3.1 to -1.1
SecondaryChange in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26

Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) is a self-reported assessment of perceived effect of weight on quality of life. It consists of 31 items organized in 5 domains (physical function, self-esteem, sexual life, public distress and work). IWQOL-Lite 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.

Time frame:
Baseline to Week 26
Reported as:
Least squares mean · units on a scale
Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 26
units on a scaleNB + CLIUsual Care
Change in Patient-reported Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite) Total Score From Baseline to Week 2616.4 ± 1.50-1.0 ± 1.41
Statistical analysis
  • NB + CLI vs Usual Care · ANCOVA · p = <0.0001 · Mean difference (net): 17.4 · 95% CI 13.45 to 21.36

Adverse events

Collected over Day 1 through Week 78. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NB + CLI (Controlled Treatment Period)—1/153 (0.7%)26/153 (17%)
Usual Care (Controlled Treatment Period)—0/89 (0%)0/89 (0%)
All Subjects (Entire Study)—2/242 (0.8%)32/242 (13.2%)
Most frequent serious events
Most frequent serious events
EventNB + CLI (Controlled Treatment Period)Usual Care (Controlled Treatment Period)All Subjects (Entire Study)
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1530/892/242
Most frequent other events
Most frequent other events
EventNB + CLI (Controlled Treatment Period)Usual Care (Controlled Treatment Period)All Subjects (Entire Study)
NauseaGastrointestinal disorders16/1530/8917/242
AnxietyPsychiatric disorders5/1530/895/242
HeadacheNervous system disorders2/1530/894/242
InsomniaPsychiatric disorders2/1530/893/242
DizzinessNervous system disorders1/1530/893/242
ConstipationGastrointestinal disorders0/1530/893/242

Baseline characteristics

Baseline analysis was based on the Intent-to-Treat (ITT) population which comprised all subjects randomized to NB + CLI who received at least 1 dose of study medication and all subjects randomly assigned to Usual Care who received their baseline lifestyle intervention program instruction.

Age, Continuous
Age, Continuous(years)NB + CLIUsual CareTotal
Mean46.1 ± 9.6647.0 ± 9.9846.5 ± 9.77
Sex: Female, Male
Sex: Female, Male(Participants)NB + CLIUsual CareTotal
Female12577202
Male281240
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)NB + CLIUsual CareTotal
Hispanic or Latino459
Not Hispanic or Latino14984233
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)NB + CLIUsual CareTotal
American Indian or Alaska Native011
Asian101
Native Hawaiian or Other Pacific Islander000
Black or African American282452
White12464188
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)NB + CLIUsual CareTotal
United States15389242
Weight
Weight(kg)NB + CLIUsual CareTotal
Mean101.4 ± 15.09100.2 ± 16.58100.9 ± 15.63
Baseline BMI
Baseline BMI(kg/m^2)NB + CLIUsual CareTotal
Mean36.33 ± 4.20036.26 ± 4.36936.31 ± 4.254
08

Study locations

15 sites
  • Radiant Research
    Denver, Colorado 80239, United States
  • Radiant Research, Inc.
    Saint Louis, Missouri 63151, United States
  • PMG Research of Raleigh
    Cary, North Carolina 27518, United States
  • PMG Research of Winston-Salem
    Hickory, North Carolina 28601, United States
  • PMG Research of Raleigh
    Raleigh, North Carolina 27609, United States
  • PMG Research of Salisbury
    Salisbury, North Carolina 28144, United States
  • PMG Research of Wilmington, LLC
    Wilmington, North Carolina 28401, United States
  • Radiant Research-Akron
    Akron, Ohio 44311, United States
  • Radiant Research, Inc.
    Columbus, Ohio 43212, United States
  • Radiant Research
    Anderson, South Carolina 29621, United States
  • Radiant Research, Greer
    Greer, South Carolina 29651, United States
  • PMG Research of Charleston
    Mount Pleasant, South Carolina 29464, United States
  • PMG Research of Bristol
    Bristol, Tennessee 37620, United States
  • Radiant Research Dallas-North
    Dallas, Texas 75231, United States
  • Radiant Research, SLC
    Salt Lake City, Utah 84107, United States
09

References and documents

Publications

  • Halseth A, Shan K, Walsh B, Gilder K, Fujioka K. Method-of-use study of naltrexone sustained release (SR)/bupropion SR on body weight in individuals with obesity. Obesity (Silver Spring). 2017 Feb;25(2):338-345. doi: 10.1002/oby.21726. Epub 2016 Dec 27. PubMed 28026920 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01764386
Lead sponsor
Orexigen Therapeutics, Inc
Responsible party
Sponsor
First posted
Jan 9, 2013
Start date
Feb 2013
Primary completion
Sep 2014
Completion
Sep 2014
Results posted
Nov 26, 2015
Last update
Dec 29, 2015

Study contacts

Senior Vice President, Head of Global Development
study director · Orexigen Therapeutics, Inc

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Overweight→

Other studies from this sponsor

Orexigen Therapeutics, Inc

Start the discussion