ObesityPhase 2NCT00364871
Efficacy and Safety Study of Combination Therapy to Treat Uncomplicated Obesity
A Phase 2 study testing naltrexone and bupropion SR in people with Obesity, run by Orexigen Therapeutics, Inc at 7 sites in United States.
Trial summary
The purpose of this study is to determine the efficacy and safety of 3 combinations of naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- naltrexone and bupropion SR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 410 participants
- Where
- 7 sitesUnited States
- Study dates
- Apr 2005to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female and male subjects, 18 to 60 years of age
- Have body mass index (BMI) of 30 to 40 kg/m2
- Free from clinically significant illness or disease as determined by medical history and physical examination
- Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to baseline
- Normotensive (systolic <140 mm Hg; diastolic <90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers, beta-blockers and clonidine. Medical regimen must be stable for at least 6 weeks
- LDL cholesterol < 190 mg/dL and triglycerides < 400 mg/dL. Medications for treatment of dyslipidemia are allowed as long as medical regimen has been stable for at least 6 weeks
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- No clinically significant abnormality of serum albumin, blood urea nitrogen, creatinine, calcium and phosphorus
- Bilirubin, ALT and AST within 1.5 x ULN
- No clinically significant abnormality of hematocrit, white blood cell count, white cell differential, or platelets
- Fasting glucose less than 140 mg/dL on no hypoglycemic agents
- No clinically significant abnormality on urinalysis
- TSH within 1.5 x ULN, normal T3, if TSH below lower limit of normal
- Negative serum pregnancy test in women with intact uterus
- Score < 11 for depression and score < 11 for anxiety on Hospital Anxiety and Depression (HAD) Scale
- ECG: no clinically significant abnormality
- Score of zero on the Mood Assessment questionnaire and a response of "No" to the Bipolar Disorder Questions
- If female with child-bearing potential, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after discontinuation of study drugs
- Able to comply with all required study procedures and schedule
- Willing and able to give written informed consent
Who cannot join
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome)
- Serious medical condition or medical condition that limits participation in the prescribed exercise program: (e.g. unstable cardiovascular disease including congestive heart failure, angina pectoris, and myocardial infarction; stroke; claudication; acute limb ischemia; acute renal or hepatic disorder; renal, hepatic or respiratory insufficiency)
- Active malignancy or history of malignancy (other than non-melanoma skin cancer or surgically cured cervical cancer) within 5 years of enrollment
- Serious psychiatric condition (e.g., any history of bipolar disorder, psychosis, suicidal attempt or post-partum depression; a history of major depression, suicidal ideation or antidepressant use within 1 year)
- Type I or Type II diabetes mellitus requiring pharmacotherapy
- Excluded concomitant medications: anorectic agents; weight loss agents; dietary supplements to promote muscle building, enhance mood, or reduce appetite; adrenergic blockers; beta blockers; anti-psychotic agents; clonidine; theophylline; cimetidine; oral corticosteroids; anti-depressant; topiramate; Depo-Provera®, smoking cessation agents; frequent, known use of opioid or opioid-like analgesics
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- History of surgical intervention for obesity
- History of seizure disorder or predisposition to seizures (e.g., history of cerebrovascular accident, significant head trauma, brain surgery, skull fracture, subdural hematoma, or febrile seizures)
- History of bulimia or anorexia nervosa
- History of drug or alcohol abuse within 5 years
- History of treatment with bupropion, or naltrexone within 12 months
- History of hypersensitivity to bupropion, or naltrexone
- Use of drugs, herbs, or dietary supplements known to significantly affect body weight within one month of baseline
- Use of investigational drug, device or procedure within 90 days
- Participation in any previous clinical trial conducted by Orexigen Therapeutics
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
CSRA Partners in Health, Inc
Augusta, Georgia, 30909
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
MUSC Weight Management Center
Charleston, South Carolina, 29425
Center for Nutrition and Preventive Medicine
Charlotte, North Carolina, 28211
Duke University Medical Center
Durham, North Carolina, 27710
UK Clinical Research Organization
Lexington, Kentucky, 40536
Scripps Clinic Del mar
San Diego, California, 92130
About this study
Official title: Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study of Combination Therapy for Safety and Efficacy in Subjects With Uncomplicated Obesity
The purpose of this study is to determine the efficacy and safety of 3 combinations of naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo.
Read the detailed description
A completed proof of concept study, OT-101 (Data on File, Orexigen Therapeutics, 2005), demonstrated that a combination of 300 mg bupropion SR and 50 mg naltrexone was associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity.
The hypothesis for the current trial is that by adjusting the doses and titration schedules of bupropion SR and naltrexone greater efficacy and improved tolerability can be achieved. In this trial, a higher dose of bupropion and 2 lower doses of naltrexone than utilized in the previous trial (OT-101) will be evaluated. The doses of both drugs will be titrated over 4 weeks and administered twice a day. There are 2 cohorts. At each site, cohort 2 recruitment began as soon as cohort 1 enrollment was completed. Cohort 1 treatment groups are (60 per group):
- Group 1: Bupropion SR (400 mg/day) plus Naltrexone (48 mg/day)
- Group 2: Bupropion SR (400 mg/day) plus Naltrexone (16 mg/day)
- Group 3: Bupropion SR (400 mg/day) plus N-Placebo
- Group 4: B-placebo plus Naltrexone (48 mg/day)
- Group 5: B-Placebo plus N-Placebo
Cohort treatment 2 Groups are:
- Group 6: B-Placebo plus N-Placebo (n=20)
- Group 7: Bupropion SR (400 mg/day) plus Naltrexone (32 mg/day)(n=60)
- Conditions
- Obesity
- Being tested
- naltrexone and bupropion SR
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naltrexone and bupropion SRDrug
naltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Bupropion SR (400 mg/day) plus Naltrexone (48 mg/day) Receives: Drug: naltrexone and bupropion SR |
| 2 | Experimental | Bupropion SR (400 mg/day) plus Naltrexone (16 mg/day) Receives: Drug: naltrexone and bupropion SR |
| 3 | Active comparator | Bupropion SR (400 mg/day) Receives: Drug: naltrexone and bupropion SR |
| 4 | Active comparator | Naltrexone (48 mg/day) Receives: Drug: naltrexone and bupropion SR |
| 5 | Placebo comparator | B-Placebo plus N-Placebo Receives: Drug: naltrexone and bupropion SR |
| 6 | Placebo comparator | B-Placebo plus N-Placebo Receives: Drug: naltrexone and bupropion SR |
| 7 | Experimental | Bupropion SR (400 mg/day) plus Naltrexone (32 mg/day) Receives: Drug: naltrexone and bupropion SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in total body weight
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2006 (estimated)
- Study startApr 2005
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 410 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orexigen Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Frank Greenway, MD, Principal investigator, Pennington Biomedical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00364871
- Sponsor's protocol ID
- NB201
- Status last verified
- Apr 2008
- First submitted
- 14 Aug 2006
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Multicenter, Randomized, Double Blind, Placebo Controlled Study of Combination Therapy for Safety and Efficacy in Subjects With Uncomplicated Obesity
- ClinicalTrials.gov ID
- NCT00364871
- Acronym / sponsor ID
- NB201
- Conditions
- Obesity
- Keywords
- Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 410 participants (actual)
- Lead sponsor
- Orexigen Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 16 Aug 2006 (estimated)
- Results
- Not posted in the source record
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 the efficacy and safety of 3 combinations of naltrexone and bupropion SR compared to naltrexone alone, bupropion SR alone or placebo.
Detailed description
A completed proof of concept study, OT-101 (Data on File, Orexigen Therapeutics, 2005), demonstrated that a combination of 300 mg bupropion SR and 50 mg naltrexone was associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity.
The hypothesis for the current trial is that by adjusting the doses and titration schedules of bupropion SR and naltrexone greater efficacy and improved tolerability can be achieved. In this trial, a higher dose of bupropion and 2 lower doses of naltrexone than utilized in the previous trial (OT-101) will be evaluated. The doses of both drugs will be titrated over 4 weeks and administered twice a day. There are 2 cohorts. At each site, cohort 2 recruitment began as soon as cohort 1 enrollment was completed. Cohort 1 treatment groups are (60 per group):
- Group 1: Bupropion SR (400 mg/day) plus Naltrexone (48 mg/day)
- Group 2: Bupropion SR (400 mg/day) plus Naltrexone (16 mg/day)
- Group 3: Bupropion SR (400 mg/day) plus N-Placebo
- Group 4: B-placebo plus Naltrexone (48 mg/day)
- Group 5: B-Placebo plus N-Placebo
Cohort treatment 2 Groups are:
- Group 6: B-Placebo plus N-Placebo (n=20)
- Group 7: Bupropion SR (400 mg/day) plus Naltrexone (32 mg/day)(n=60)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: naltrexone and bupropion SRBupropion SR (400 mg/day) plus Naltrexone (48 mg/day) |
| 2 | Experimental | Drug: naltrexone and bupropion SRBupropion SR (400 mg/day) plus Naltrexone (16 mg/day) |
| 3 | Active comparator | Drug: naltrexone and bupropion SRBupropion SR (400 mg/day) |
| 4 | Active comparator | Drug: naltrexone and bupropion SRNaltrexone (48 mg/day) |
| 5 | Placebo comparator | Drug: naltrexone and bupropion SRB-Placebo plus N-Placebo |
| 6 | Placebo comparator | Drug: naltrexone and bupropion SRB-Placebo plus N-Placebo |
| 7 | Experimental | Drug: naltrexone and bupropion SRBupropion SR (400 mg/day) plus Naltrexone (32 mg/day) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Female and male subjects, 18 to 60 years of age
- Have body mass index (BMI) of 30 to 40 kg/m2
- Free from clinically significant illness or disease as determined by medical history and physical examination
- Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to baseline
- Normotensive (systolic <140 mm Hg; diastolic <90 mm Hg). Anti-hypertensive medications are allowed with the exception of adrenergic blockers, beta-blockers and clonidine. Medical regimen must be stable for at least 6 weeks
Key exclusion criteria (16 listed)
- Obesity of known endocrine origin (e.g., untreated hypothyroidism, Cushing's syndrome)
- Serious medical condition or medical condition that limits participation in the prescribed exercise program: (e.g. unstable cardiovascular disease including congestive heart failure, angina pectoris, and myocardial infarction; stroke; claudication; acute limb ischemia; acute renal or hepatic disorder; renal, hepatic or respiratory insufficiency)
- Active malignancy or history of malignancy (other than non-melanoma skin cancer or surgically cured cervical cancer) within 5 years of enrollment
- Serious psychiatric condition (e.g., any history of bipolar disorder, psychosis, suicidal attempt or post-partum depression; a history of major depression, suicidal ideation or antidepressant use within 1 year)
- Type I or Type II diabetes mellitus requiring pharmacotherapy
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 and bupropion SRnaltrexone 16, 32 or 48 mg/day and bupropion SR 400 mg/day | Drug | 1, 2, 3, 4, 5, 6, 7 |
Primary outcome
Percentage change in total body weight
Time frame: baseline to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
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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.
Frank Greenway, MD principal investigator
Pennington Biomedical Research Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing naltrexone and bupropion SR in people with Obesity, run by Orexigen Therapeutics, Inc at 7 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 19 inclusion and 16 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 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage change in total body weight (time frame: baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2008.