Status:
COMPLETED
Efficacy and Safety Study of Combination Therapy to Treat Uncomplicated Obesity
Lead Sponsor:
Orexigen Therapeutics, Inc
Conditions:
Obesity
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.
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 l...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT00364871
Start Date
April 1 2005
End Date
March 1 2007
Last Update
April 22 2008
Active Locations (7)
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1
Scripps Clinic Del mar
San Diego, California, United States, 92130
2
CSRA Partners in Health, Inc
Augusta, Georgia, United States, 30909
3
UK Clinical Research Organization
Lexington, Kentucky, United States, 40536
4
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808