A Study Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Naltrexone SR/ Bupropion SR Therapy in Overweight or Obese Subjects

Completed · Phase 2 · Has a placebo group

Conditions studied: Obesity

In brief

The purpose of this study was to assess the effect of naltrexone SR/bupropion SR (NB) on brain function in response to food cues using functional magnetic resonance imaging in overweight or obese subjects.

Key facts

Study ID: NCT00711477
Run by: Orexigen Therapeutics, Inc
People needed: 46
Starts: 2008-09-01
Expected to finish: 2010-06-01
Last updated by the study team: 2015-01-06

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Right-handed, female subjects, 18 to 45 years of age
Body mass index (BMI) ≥ 27 and ≤ 40 kg/m²
Free from clinically significant illness or disease as determined by medical history and physical examination
Able to provide proof of identity during the enrollment process
In good general health, without clinically significant medical history, physical examination findings or laboratory results
Laboratory values obtained within 30 days of study entry within normal range for healthy volunteers.
Normal urinalysis on initial screening day defined as: negative glucose, negative or trace protein, and negative or trace hemoglobin
Normotensive (systolic ≤140 mm Hg, diastolic ≤90 mm hg)
On no concomitant medications with the exception of oral contraceptives, vitamins, and over the counter pain, indigestion or allergy medication
All women of child bearing potential must be non-lactating, must have a negative STAT pregnancy test, and agree to use effective contraception methods throughout study period and for 30 days after discontinuation of study drug. The following are considered effective methods of contraception: Combination or progestin-only birth control pills (oral contraceptives), vaginal contraceptive rings, contraceptive patches, Depo Provera, intrauterine devices, barrier methods with spermicide (condom/foam, diaphragm/ spermicide), abstinence. (Subjects who have had a tubal ligation, hysterectomy or are post-menopausal for 2 years are considered NOT to be of child bearing potential)
For women not using hormonal methods of contraception, should be in the follicular phase of the menstrual cycle at the baseline visit.
Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to baseline. On screening and study days, we will test the subjects' urine for presence of nicotinine/cotinine (STAT) test as confirmatory evidence of being a non-smoker in addition to their self-report. A Tobacco Questionnaire and Breath CO will also be administered for eligibility on the day of screening for confirmation purposes.
No clinically significant abnormality on ECG, baseline QTc <470
Able to comply with all required study procedures
Available for follow up for the duration of the study
Willing and able to give written informed consent

You may not qualify if…

Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, Cushing's syndrome, Prader Willi Syndrome, established Polycystic Ovary Syndrome)
Inability to participate in fMRI scanning sessions
History of occupational exposure to metal flakes in their bodies or eyes.
History of known indwelling ferromagnetic metals or fragments.
History of acute or chronic illness that requires medical therapy including active gastrointestinal conditions that might interfere with drug absorption
History or presence of hepatic, renal, cardiovascular or gastrointestinal diseases
Type I or Type II diabetes mellitus requiring pharmacotherapy
Active malignancy or history of malignancy (other than non-melanoma skin cancer or surgically cured cervical cancer) within 5 years of enrollment
Serious psychiatric illness, including lifetime history of psychiatric hospitalization, suicide attempt, bipolar disorder, schizophrenia or other psychosis, bulimia, or anorexia nervosa; current serious personality disorder, (e.g. borderline or antisocial), major depressive disorder within the previous two years, suicidal ideation or need for psychiatric treatment in the previous 6 months.
In need of medications for the treatment of a psychiatric disorder within the previous 6 months prior to randomization.
IDS-SR total score >25 or scores >1 in items 5 (sadness), 6 (irritability), 7 (anxiety/tension) or 18 (suicidality)
History of alcohol or drug abuse, current or within 2 years
Unable to abstain from caffeinated product consumption for at least 48 hours
History of surgical intervention for obesity
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.
History of hypersensitivity to bupropion or naltrexone
History of seizure disorder or predisposition to seizures (e.g., history of cerebrovascular accident, brain surgery, head trauma with ≥5 minutes loss of consciousness, concussion symptoms lasting ≥ 15 minutes, skull fracture, subdural hematoma, or febrile seizures) or need for therapy with anticonvulsant medication.
History of treatment with bupropion or naltrexone within 12 months
Positive urine drug screen - STAT test performed on each day of study.
Pregnant or breast-feeding
Planned surgical procedure or trip that can impact the conduct of the study
Use of investigational drug, device or procedure within 30 days
Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Participation in any previous clinical trial sponsored by Orexigen Therapeutics.
Study personnel, sponsor representatives and their immediate families.

Where it is running

Brookhaven National Laboratory Medical Department — Upton, New York, United States

Full record on ClinicalTrials.gov

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