Efficacy and Safety Study of Combination Therapy to Treat Uncomplicated Obesity

Completed · Phase 2

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00364871

Run by

Orexigen Therapeutics, Inc

People needed

410

Starts

2005-04-01

Expected to finish

2007-03-01

Last updated by the study team

2008-04-22

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scripps Clinic Del mar — San Diego, California, United States
• CSRA Partners in Health, Inc — Augusta, Georgia, United States
• UK Clinical Research Organization — Lexington, Kentucky, United States
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States
• Center for Nutrition and Preventive Medicine — Charlotte, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• MUSC Weight Management Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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