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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Drug: Comparator: sibutramine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00914212

0000-103

2009_597

103

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Sibutramine

Treatment:

Drug: Comparator: sibutramine

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo