A Functional Magnetic Resonance Imaging (fMRI) Study in Overweight and Obese Men (0000-103)

NCT00914212 — Phase 1, Completed, 15 participants, Merck Sharp & Dohme LLC

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A Functional Magnetic Resonance Imaging (fMRI) Study of the Reproducibility and the Effect of Sibutramine During Fasted and Fed Conditions in Healthy Overweight and Obese Men

Registry	NCT00914212
Status	Completed
Phase	Phase 1
Study type	Interventional; randomized, crossover, masking: double, diagnostic
Enrollment	15 (Actual)
Sponsor	Merck Sharp & Dohme LLC (Industry)
Conditions	Obesity
Interventions	Placebo, Comparator: sibutramine (Drug)
Dates	start 2009-05-01, primary completion 2009-08-01, completion 2009-08-01, first posted 2009-06-04, last updated 2015-10-12

-Summary

This study will determine whether BOLD-fMRI can be used to probe hunger and satiety states in healthy overweight or obese men and also whether fasted/fed fMRI signals can be modulated by sibutramine.

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+Arms and interventions

Arm	Type	Interventions	Description
1	Active comparator	Drug: Comparator: sibutramine	Sibutramine
2	Placebo comparator	Drug: Placebo	Placebo

Placebo (Drug): Single dose placebo to sibutramine in two of three treatment periods.
Comparator: sibutramine (Drug), also known as sibutramine: Single dose sibutramine 30 mg (2 x 15 mg) in one of three treatment periods.

+Outcome measures

Primary outcomes

Average percent signal change of the top 20% of activated voxels (AvgPSC20) during the fasted condition over six primary brain regions of interest (ROI) [Day 1]

Secondary outcomes

Intraclass coefficient of correlation of the AvgPSC20 assessed during the fed and fasted conditions over the six ROIs [Day 1]
Regional cerebral blood flow (rCBF) during the fasted condition with placebo or sibutramine in the six ROIs [Day 1]
AvgPSC20 in the fed condition with placebo or sibutramine in the six ROIs [Day 1]
Difference in PSC20 during fasted and fed conditions with placebo or sibutramine in the six ROIs [Day 1]
rCBF during the fed condition with placebo or sibutramine in the six ROIs [Day 1]
Difference in rCBF during fasted and fed conditions with placebo or sibutramine in the six ROIs [Day 1]
Test-retest reliability of rCBF in the six ROIs during the fasted and fed states in men receiving placebo [Day 1]

+Eligibility

Sex: Male, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Subject is a male between 18 and 45 years of age
* Subject has a body mass index (BMI) between 28 and 35 kg/m\^2
* Subject does not weigh more than 140 kg (309 lbs) at the screening visit
* Subject is right-handed
* Subject is a non-smoker
* Subject is in generally good health
* Subject has normal or corrected to normal vision

Exclusion Criteria:

* Subject works a night shift within 3 days of each treatment visit
* Subject has permanent cosmetic or metallic objects in his body
* Subject has attention deficit hyperactivity disorder (ADHD)
* Subject has or had sleep apnea
* Subject has a history of neurological disorders
* Subject has a history of any clinically significant disease or condition
* Subject is vegan or vegetarian
* Subject has a history of eating disorders
* Subject has had previous bariatric surgery

+Investigators

Medical Monitor, Study director, Merck Sharp & Dohme LLC