ObesityPhase 3NCT00456521
A Safety and Efficacy Study of Naltrexone SR/Bupropion SR and Placebo in Overweight and Obese Subjects Participating in an Intensive Behavior Modification Program
A Phase 3 study testing Naltrexone SR 32 mg/ bupropion SR 360 mg/ day and Intensive group lifestyle modification counseling in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 9 sites in United States.
Trial summary
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Naltrexone SR 32 mg/ bupropion SR 360 mg/ day and Intensive group lifestyle modification counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 793 participants
- Where
- 9 sitesUnited States
- Study dates
- Mar 2007to Dec 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male subjects aged 18 to 65 years (inclusive)
- Body mass index (weight [kg]/height [m²]) ≥30 and ≤45 kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45 kg/m² for subjects with controlled hypertension and/or dyslipidemia
- Non-smoker and had not used tobacco or nicotine products for at least 6 months before screening
- Normotensive (systolic ≤140 mm Hg and diastolic ≤90 mm Hg). Anti-hypertensive medications were allowed with the exception of alpha-adrenergic blockers, beta-blockers, and clonidine. Medical regimen was to be stable for at least 8 weeks.
- Low-density lipoprotein level <190 mg/dL and triglycerides level <400 mg/dL. Medications for the treatment of dyslipidemia were allowed as long as the medical regimen had been stable for at least 8 weeks.
- No clinically significant abnormality of serum albumin, blood urea nitrogen (BUN), creatinine, bilirubin, calcium and phosphorus
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- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 2.5 times upper limit of normal (ULN)
- No clinically significant abnormality of hematocrit, white blood cell (WBC) count, WBC differential, or platelets
- Fasting glucose ≤126 mg/dL and not receiving hypoglycemic agents
- No clinically significant abnormality on urinalysis
- Thyroid stimulating hormone (TSH) within 1.5 times ULN or normal triiodothyronine (T3), if TSH was below normal limits
- Female subjects of childbearing potential had a negative serum pregnancy test
- An IDS-SR score <2 on individual items: 5 (sadness), 6 (irritability), 7 (anxiety/tension), and 18 (suicidality) and an IDS-SR total score <30
- Female subjects of childbearing potential were non-lactating and agreed to continue to use effective contraception throughout the study and 30 days after discontinuation of study drug
- Completed a food diary for 6 of 7 consecutive days during screening
- Able to comply with all required study procedures and schedule
- Able to speak and read English
- Provided written informed consent
Who cannot join
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established polycystic ovary syndrome)
- Serious medical condition (including but not limited to renal or hepatic insufficiency; congestive heart failure, angina pectoris, myocardial infarction, stroke, claudication, or acute limb ischemia; history of malignancy with exception of non-melanoma skin cancer or surgically cured cervical cancer)
- Serious psychiatric illness (e.g., lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, e.g., borderline; severe major depressive disorder, recent [previous 6 months] suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness)
- Response to the bipolar disorder questions that indicated the presence of bipolar disorder.
- Required medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months
- History of drug or alcohol abuse or dependence within 1 year
Show all 20Show fewer
- Type I or Type II diabetes mellitus
- Baseline ECG with a corrected QT (QTc) interval (using Bazett's formula >450 millisecond (msec) [males] and >470 msec [females]) or the presence of any clinically significant cardiac abnormalities, including but not limited to patterns consistent with myocardial ischemia, electrolyte abnormalities, or atrial or ventricular dysrhythmia or significant conduction abnormalities
- Received excluded concomitant medications: any psychotropic agents (including antipsychotic, antidepressant, anxiolytic, mood stabilizer or anticonvulsant agents) with the exception of low-dose benzodiazepine or hypnotic agents for the treatment of insomnia; any anorectic or weight loss agents; any over-the-counter dietary supplements with psychoactive, appetite or weight effects; alpha-adrenergic blockers; beta-blockers; clonidine; coumadin; theophylline; cimetidine; oral corticosteroids; topiramate, Depo-Provera®; smoking cessation agents; regular use of opioid or opioid-like analgesics
- History of surgical or device (e.g., lap band) intervention for obesity
- History of seizures of any etiology, or of predisposition to seizures (e.g., history of cerebrovascular accident, head trauma with >5 minutes loss of consciousness, concussion symptoms lasting >15 minutes, brain surgery, skull fracture, subdural hematoma, or febrile seizures)
- History of treatment with bupropion or naltrexone within the preceding 12 months
- History of hypersensitivity or intolerance to bupropion or naltrexone
- Used drugs, herbs, or dietary supplements believed to significantly affect body weight or participated in a weight loss management program within one month prior to baseline
- Loss or gained >4.0 kilograms within the previous 3 months
- Females who were pregnant or breast-feeding or planning to become pregnant during the study period or within 30 days of discontinuing study drug
- Planned surgical procedure that could impact the conduct of the study
- Received any investigational drug or used an experimental device or procedure within the previous 30 days
- Participated in any previous clinical trial conducted by Orexigen
- Had any condition that in the opinion of the investigator made the subject unsuitable for inclusion into the study
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Medical University of S. Carolina Weight Management Center
Charleston, South Carolina, 29425
Center for Human Nutrition, University of Colorado Health Services Center
Denver, Colorado, 80220
Univ. of Florida, College of Public Health, and Health Professions
Gainesville, Florida, 32611
Behavioral Medicine Research Center
Houston, Texas, 77030
University of California, San Diego: Dept of Family & Preventive Medicine
La Jolla, California, 92093
New York Obesity Research Center, St. Luke's-Roosevelt Hospital Center
New York, New York, 10025
Center for Weight and Eating Disorders, School of Med., University of Penn.
Philadelphia, Pennsylvania, 19104
Center for Obesity Research and Education, Temple University
Philadelphia, Pennsylvania, 19140
Washington Univ. Center for Human Nutrition
St Louis, Missouri, 63110
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.
Read the detailed description
The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg). Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study evaluated weight loss in subjects participating in such a comprehensive program who received a combination of naltrexone SR and bupropion SR, or placebo.
- Conditions
- Obesity, Overweight
- Being tested
- Naltrexone SR 32 mg/ bupropion SR 360 mg/ day, Placebo, Intensive group lifestyle modification counseling
- Keywords
- Obesity, Behavior Modification
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone SR 32 mg/ bupropion SR 360 mg/ dayDrug
Also called NB32
PlaceboDrug
Intensive group lifestyle modification counselingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| NB32 | Experimental | Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group lifestyle modification counseling Receives: Drug: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day; Behavioral: Intensive group lifestyle modification counseling |
| Placebo | Placebo comparator | Placebo with intensive group lifestyle modification counseling Receives: Drug: Placebo; Behavioral: Intensive group lifestyle modification counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary: Body Weight- Mean Percent Change
Measured: Baseline, 56 weeks
Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease
Measured: Baseline, 56 weeks
Secondary outcomes (16)
Body Weight- Proportion of Subjects With ≥10% Decrease
Measured: Baseline, 56 weeks
Change in Waist Circumference
Measured: Baseline, 56 weeks
Change in Fasting Triglycerides Levels, Using Log-transformed Data
Measured: Baseline, 56 weeks
Change in Fasting Insulin Levels, Using Log-transformed Data
Measured: Baseline, 56 weeks
Change in Fasting HDL Cholesterol Levels
Measured: Baseline, 56 weeks
Change in IWQOL-Lite Total Scores
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
Measured: Baseline, 56 weeks
Change in HOMA-IR Levels, Using Log-transformed Data
HOMA-IR= Homeostasis Model Assessment-Insulin Resistance
Measured: Baseline, 56 weeks
Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data
Measured: Baseline, 56 weeks
Change in Fasting Blood Glucose Levels
Measured: Baseline, 56 weeks
Change in Fasting LDL Cholesterol
Measured: Baseline, 56 weeks
Change in Systolic Blood Pressure
Measured: Baseline, 56 weeks
Change in Diastolic Blood Pressure
Measured: Baseline, 56 weeks
Change in IDS-SR Total Scores
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.
Measured: Baseline, 56 weeks
Change in Food Craving Inventory Sweets Subscale Scores
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).
Measured: Baseline, 56 weeks
Change in Food Craving Inventory Carbohydrates Subscale Scores
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).
Measured: Baseline, 56 weeks
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire
Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult
Measured: Baseline, 56 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 793 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456521
- Sponsor's protocol ID
- NB-302
- Other IDs
- COR-BMOD
- Status last verified
- Dec 2014
- First submitted
- 3 Apr 2007
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wadden TA, Foreyt JP, Foster GD, Hill JO, Klein S, O'Neil PM, Perri MG, Pi-Sunyer FX, Rock CL, Erickson JS, Maier HN, Kim DD, Dunayevich E. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial. Obesity (Silver Spring). 2011 Jan;19(1):110-20. doi: 10.1038/oby.2010.147. Epub 2010 Jun 17.
PubMed 20559296
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone Sustained Release (SR)/Bupropion SR and Placebo in Subjects With Obesity Participating in a Behavior Modification Program
- ClinicalTrials.gov ID
- NCT00456521
- Acronym / sponsor ID
- NB-302
- Conditions
- Obesity, Overweight
- Keywords
- Obesity, Behavior Modification
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 793 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Posted 21 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a combination of naltrexone SR and bupropion SR is safe and effective in treating obesity and leads to greater weight loss when given with a group lifestyle modification program than with group lifestyle modification alone.
Detailed description
The combination of group lifestyle modification counseling and pharmacotherapy has recently been shown to result in nearly twice the average weight loss at one year (12.1 kg) as pharmacotherapy alone (sibutramine, 5.0 kg) or lifestyle modification counseling alone (6.7 kg). Combining pharmacotherapy with a comprehensive program of diet, exercise and group lifestyle modification counseling may provide the best weight loss regimen. This study evaluated weight loss in subjects participating in such a comprehensive program who received a combination of naltrexone SR and bupropion SR, or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NB32 | Experimental | Drug: Naltrexone SR 32 mg/ bupropion SR 360 mg/ day, Behavioral: Intensive group lifestyle modification counselingNaltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group lifestyle modification counseling |
| Placebo | Placebo comparator | Drug: Placebo, Behavioral: Intensive group lifestyle modification counselingPlacebo with intensive group lifestyle modification counseling |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Female or male subjects aged 18 to 65 years (inclusive)
- Body mass index (weight [kg]/height [m²]) ≥30 and ≤45 kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45 kg/m² for subjects with controlled hypertension and/or dyslipidemia
- Non-smoker and had not used tobacco or nicotine products for at least 6 months before screening
- Normotensive (systolic ≤140 mm Hg and diastolic ≤90 mm Hg). Anti-hypertensive medications were allowed with the exception of alpha-adrenergic blockers, beta-blockers, and clonidine. Medical regimen was to be stable for at least 8 weeks.
- Low-density lipoprotein level <190 mg/dL and triglycerides level <400 mg/dL. Medications for the treatment of dyslipidemia were allowed as long as the medical regimen had been stable for at least 8 weeks.
Key exclusion criteria (20 listed)
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established polycystic ovary syndrome)
- Serious medical condition (including but not limited to renal or hepatic insufficiency; congestive heart failure, angina pectoris, myocardial infarction, stroke, claudication, or acute limb ischemia; history of malignancy with exception of non-melanoma skin cancer or surgically cured cervical cancer)
- Serious psychiatric illness (e.g., lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, and anorexia nervosa; current serious personality disorder, e.g., borderline; severe major depressive disorder, recent [previous 6 months] suicide attempt or current active suicidal ideation, recent hospitalization due to psychiatric illness)
- Response to the bipolar disorder questions that indicated the presence of bipolar disorder.
- Required medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naltrexone SR 32 mg/ bupropion SR 360 mg/ dayAlso: NB32 | Drug | NB32 |
| Placebo | Drug | Placebo |
| Intensive group lifestyle modification counseling | Behavioural | NB32, Placebo |
Primary outcome
Co-primary: Body Weight- Mean Percent Change
Time frame: Baseline, 56 weeks
Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease
Time frame: Baseline, 56 weeks
16 secondary outcomes
Body Weight- Proportion of Subjects With ≥10% Decrease
Time frame: Baseline, 56 weeks
Change in Waist Circumference
Time frame: Baseline, 56 weeks
Change in Fasting Triglycerides Levels, Using Log-transformed Data
Time frame: Baseline, 56 weeks
Change in Fasting Insulin Levels, Using Log-transformed Data
Time frame: Baseline, 56 weeks
Change in Fasting HDL Cholesterol Levels
Time frame: Baseline, 56 weeks
Change in IWQOL-Lite Total Scores
Time frame: Baseline, 56 weeks
Change in HOMA-IR Levels, Using Log-transformed Data
Time frame: Baseline, 56 weeks
Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data
Time frame: Baseline, 56 weeks
Change in Fasting Blood Glucose Levels
Time frame: Baseline, 56 weeks
Change in Fasting LDL Cholesterol
Time frame: Baseline, 56 weeks
Change in Systolic Blood Pressure
Time frame: Baseline, 56 weeks
Change in Diastolic Blood Pressure
Time frame: Baseline, 56 weeks
Change in IDS-SR Total Scores
Time frame: Baseline, 56 weeks
Change in Food Craving Inventory Sweets Subscale Scores
Time frame: Baseline, 56 weeks
Change in Food Craving Inventory Carbohydrates Subscale Scores
Time frame: Baseline, 56 weeks
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire
Time frame: Baseline, 56 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20559296Wadden TA, Foreyt JP, Foster GD, Hill JO, Klein S, O'Neil PM, Perri MG, Pi-Sunyer FX, Rock CL, Erickson JS, Maier HN, Kim DD, Dunayevich E. Weight loss with naltrexone SR/bupropion SR combination therapy as an adjunct to behavior modification: the COR-BMOD trial. Obesity (Silver Spring). 2011 Jan;19(1):110-20. doi: 10.1038/oby.2010.147. Epub 2010 Jun 17.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone SR 32 mg/ bupropion SR 360 mg/ day and Intensive group lifestyle modification counseling in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Co-primary: Body Weight- Mean Percent Change (time frame: Baseline, 56 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00456521, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.