Efficacy and Safety Study of Combination Therapy to Treat Uncomplicated Obesity

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orexigen Therapeutics, Inc
• Treatments: Bupropion; Bupropion hydrochloride, naltrexone hydrochoride drug combination; Naltrexone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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