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ObesityPhase 3NCT00532779

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

A Phase 3 study testing Naltrexone SR 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day and Ancillary therapy in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity. 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 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day and Ancillary therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,742 participants
Where
34 sitesUnited States
Study dates
Oct 2007to May 2009
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 and male subjects, 18 to 65 years of age;
  • Have BMI ≥30 and ≤45kg/m² for subjects with uncomplicated obesity, and BMI of ≥27 and ≤45kg/m² for subjects with obesity and controlled hypertension and/or dyslipidemia;
  • Normotensive (systolic ≤140 mm Hg; diastolic ≤90 mm Hg). Anti-hypertensive medications are allowed with the exception of alpha-adrenergic blockers and clonidine; medical regimen must be stable for at least 6 weeks prior to randomization;
  • Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks prior to randomization;
  • Free of opioid medication for 7 days prior to randomization;
  • No clinically significant abnormality of serum albumin, blood urea nitrogen, creatinine, bilirubin, sodium, potassium, chloride, calcium or phosphorus;
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  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 2.5 x upper limit of normal range (ULN);
  • No clinically significant abnormality of hematocrit, white blood cell (WBC) count, white cell differential, or platelets;
  • Fasting glucose < 126 mg/dL on no hypoglycemic agents, fasting triglycerides <400 mg/dL;
  • No clinically significant abnormality on urinalysis;
  • TSH within normal limits or normal T3, if TSH is below normal limits;
  • Negative serum pregnancy test in women of child-bearing potential;
  • Negative urine drug screen;
  • IDS-SR scores < 2 on items 5 (sadness), 6 (irritability), 7 (anxiety/tension) and 18 (suicidality), and IDS-SR total score < 30;
  • Women of child bearing potential had to be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drug;
  • Able to comply with all required study procedures and schedule;
  • Able to speak and read English;
  • Willing and able to give written informed consent.

Who cannot join

  • Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome, established Polycystic Ovary Syndrome);
  • Serious medical conditions (including but not limited to ongoing renal or hepatic insufficiency, Class III or IV congestive heart failure; myocardial infarction, history of angina pectoris, claudication, or acute limb ischemia within the previous 6 months; lifetime history of stroke);
  • History of malignancy within the previous 5 years with exception of non-melanoma skin cancer or surgically cured cervical cancer;
  • A lifetime history of serious psychiatric illness, including lifetime history of bipolar disorder, schizophrenia or other psychosis, bulimia, or anorexia nervosa;
  • Current serious psychiatric illness including severe personality disorder, (e.g. borderline or antisocial), current severe major depressive disorder, recent (previous 6 months) suicide attempt, current active suicidal ideation, or recent hospitalization due to psychiatric illness;
  • A response to bipolar disorder questions indicating the presence of bipolar disorder;
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  • In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months prior to randomization;
  • History of drug or alcohol abuse or dependence (with the exception of nicotine dependence) within 1 year prior to study initiation;
  • Type 1 or Type 2 diabetes mellitus;
  • Screening ECG with a corrected QT interval by the method of Bazett (QTcB) >450 msec (men) and > 470 millisecond (msec) (women) 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;
  • Excluded concomitant medications: any psychotropic agents (including antipsychotic, antidepressant, anxiolytic, mood stabilizer, anticonvulsant agents or agents for the treatment of Attention Deficit Disorder) with the exception of low dose benzodiazepine or hypnotic agents for the treatment of insomnia (up to 2 mg lorazepam/day or equivalent dose of a benzodiazepine or hypnotic agent); any anorectic or weight loss agents; any over-the-counter dietary supplements or herbs with psychoactive, appetite or weight effects; alpha-adrenergic blockers; dopamine agonists; clonidine; coumadin; theophylline; cimetidine; oral corticosteroids; cholestyramine, cholestypol, Depo Provera®; smoking cessation agents; use of opioid or opioid-like medications, including analgesics and antitussives;
  • History of surgical or device (e.g., gastric banding) 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;
  • Initiation or discontinuation of tobacco products including inhaled tobacco (such as cigarettes, cigars, pipes, etc), chewing tobacco or snuff in the 3 months prior to randomization or planned during study participation. Use of nicotine replacement products (nicotine gum, patch) during study participation was not allowed;
  • Use of drugs, herbs, or dietary supplements believed to significantly affect body weight or participation in a weight loss management program within one month prior to randomization;
  • Loss or gain of more than 4.0 kilograms within 3 months prior to randomization;
  • Pregnant or breast-feeding women or planning to become pregnant during the study period or within 30 days of discontinuing study drug;
  • Planned surgical procedure that can impact the conduct of the study;
  • Use of investigational drug, device or procedure within the previous 30 days;
  • Participation in any previous clinical trial sponsored by Orexigen Therapeutics;
  • Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in the study;
  • Investigators, study personnel, sponsor representatives and their immediate families.

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Georgia Clinical Research

    Atlanta, Georgia, 30308

  • CSRA Partners in Health, Inc

    Augusta, Georgia, 30909

  • Covance Clinical Research Unit Austin

    Austin, Texas, 78752

  • Health Trends Research, LLC

    Baltimore, Maryland, 21209

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

  • Radiant Research

    Birmingham, Alabama, 35209

  • Radiant Research, Phoenix Southeast

    Chandler, Arizona, 85225

  • Center for Nutrition and Preventive Medicine

    Charlotte, North Carolina, 28211

  • Radiant Research

    Chicago, Illinois, 60610

  • Rapid Medical Research, Inc.

    Cleveland, Ohio, 44122

  • Central Ohio Nutrition Center, Inc.

    Columbus, Ohio, 43213

  • Internal Medicine Associates of Cordova

    Cordova, Tennessee, 38018

  • Radiant Research

    Dallas, Texas, 75231

  • Baylor Endocrine Center

    Dallas, Texas, 75246

  • Welborn Clinic

    Evansville, Indiana, 47713

  • SelfCenter, PC

    Fairhope, Alabama, 36532

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Jackson Clinic, PA

    Jackson, Tennessee, 38305

  • Central Kentucky Research Associates, Inc.

    Lexington, Kentucky, 40509

  • Miami Research Associates

    Miami, Florida, 33143

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Advance Clinical Research Institute

    Orange, California, 92869

  • Radiant Research Kansas City

    Overland Park, Kansas, 66202

  • University Clinical Research

    Pembroke Pines, Florida, 33024

  • Summit Research Network (Oregon), Inc.

    Portland, Oregon, 97210

  • Wake Research Associates, LLC

    Raleigh, North Carolina, 27612

  • Center for Nutrition and Metabolic Disorders

    Reno, Nevada, 89557

  • Radiant Research

    San Antonio, Texas, 78217

  • Oakwell Clinical Research

    San Antonio, Texas, 78218

  • Scripps Clinic Del Mar

    San Diego, California, 92130

  • VA San Diego Healthcare System

    San Diego, California, 92161

  • Medical Research Institute

    Slidell, Louisiana, 70458

  • FutureCare Studies

    Springfield, Massachusetts, 01103

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects

The purpose of this study is to determine whether 2 doses of the combination of naltrexone SR and bupropion SR are safe and effective in the treatment of obesity.

Read the detailed description

Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of 2 doses of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with uncomplicated obesity and in those with overweight/obesity and hypertension and/or dyslipidemia.

Conditions
Obesity, Overweight
Being tested
Naltrexone SR 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day, Placebo, Ancillary therapy
Keywords
Obesity, Antiobesity agents, Antiobesity drugs, Overweight drug therapy, Obese drug therapy, Weight loss drug effects, Bupropion administration and dosage, Naltrexone administration and dosage, Double blind method, Combination drug therapy, Delayed action preparations
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 16 mg/Bupropion SR 360 mg /dayDrug

    Also called NB16

  • Naltrexone SR 32 mg/Bupropion SR 360 mg /dayDrug

    Also called NB32

  • PlaceboDrug

  • Ancillary therapyBehavioural

    Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Study groups in NCT00532779
Study groupRoleWhat they receive
NB16ExperimentalNaltrexone SR 16 mg/Bupropion SR 360 mg /day with ancillary therapy
Receives: Drug: Naltrexone SR 16 mg/Bupropion SR 360 mg /day; Behavioral: Ancillary therapy
NB32ExperimentalNaltrexone SR 32 mg/Bupropion SR 360 mg /day with ancillary therapy
Receives: Drug: Naltrexone SR 32 mg/Bupropion SR 360 mg /day; Behavioral: Ancillary therapy
PlaceboPlacebo comparatorPlacebo with ancillary therapy
Receives: Drug: Placebo; Behavioral: Ancillary therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Co-primary: Body Weight- Mean Percent Change

    Measured: Baseline, 56 weeks

  2. Co-primary: Body Weight- Proportion of Subjects With ≥5% Decrease

    Measured: Baseline, 56 weeks

Secondary outcomes (16)

  1. Body Weight- Proportion of Subjects With ≥10% Decrease

    Measured: Baseline, 56 weeks

  2. Change in Waist Circumference

    Measured: Baseline, 56 weeks

  3. Change in Fasting HDL Cholesterol Levels

    Measured: Baseline, 56 weeks

  4. Change in Fasting Triglycerides Levels, Using Log-transformed Data

    Measured: Baseline, 56 weeks

  5. 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

  6. Change in High-sensitivity C Reactive Protein (Hs-CRP) Levels, Using Log-transformed Data

    Measured: Baseline, 56 weeks

  7. Change in Fasting Insulin Levels, Using Log-transformed Data

    Measured: Baseline, 56 weeks

  8. Change in Fasting Blood Glucose Levels

    Measured: Baseline, 56 weeks

  9. Change in HOMA-IR Levels, Using Log-transformed Data

    HOMA-IR= Homeostasis Model Assessment-Insulin Resistance

    Measured: Baseline, 56 weeks

  10. 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

  11. Change in Fasting LDL Cholesterol Levels

    Measured: Baseline, 56 weeks

  12. Change in Systolic Blood Pressure

    Measured: Baseline, 56 weeks

  13. Change in Diastolic Blood Pressure

    Measured: Baseline, 56 weeks

  14. 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

  15. Change in Food Craving Inventory Sweets Subscale Score

    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

  16. Change in Food Craving Inventory Carbohydrates Subscale Score

    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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2007 (estimated)
  2. Study startOct 2007
  3. Primary completionMay 2009
  4. Study completionMay 2009

Resources

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
1,742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00532779
Sponsor's protocol ID
NB-301
Other IDs
COR-I
Status last verified
Nov 2014
First submitted
19 Sep 2007
Last updated
21 Nov 2014
Data monitoring committee
Yes

Publications

  • Greenway FL, Fujioka K, Plodkowski RA, Mudaliar S, Guttadauria M, Erickson J, Kim DD, Dunayevich E; COR-I Study Group. Effect of naltrexone plus bupropion on weight loss in overweight and obese adults (COR-I): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2010 Aug 21;376(9741):595-605. doi: 10.1016/S0140-6736(10)60888-4. Epub 2010 Jul 29.

    PubMed 20673995

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Naltrexone SR 16 mg/Bupropion SR 360 mg /day, Naltrexone SR 32 mg/Bupropion SR 360 mg /day and Ancillary therapy in people with Obesity and Overweight, run by Orexigen Therapeutics, Inc at 34 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 24 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 21 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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 NCT00532779, 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 21 Nov 2014.

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