The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese but otherwise healthy subjects with over-eating behaviours.
This study is to test a new drug which may be used for treating over-eating behaviours and patterns that some overweight and obese people find difficult to control. The drug works by inhibiting the effects of messenger molecules called opioids. These opioids are naturally produced within the human body, and are involved in controlling how much we eat, and the pleasure we get from eating. We believe that GSK1521498 might be effective in the treatment of obesity because it is well known that drugs working on similar binding sites in the brain reduce the pleasure we get from eating, especially high fat or high sugar food. We also believe the effects of GSK1521498 will be greater in obese individuals with greater severity of over-eating behaviours, as measured for example by existing questionnaire scales for binge-eating or compulsive eating behaviour. We will perform a variety of simple tests using a computer, questionnaires and eating assessments to examine effects on behaviour. We will also ask people to complete questionnaires so that we can see if there are any effects on their mood.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
GSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly
Placebo will be given for up to 35 days and subjects will be assessed weekly
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom
GSK Investigational Site
Birmingham, West Midlands, United Kingdom
GSK Investigational Site
London, United Kingdom
Clinically and statistically significant weight loss
Time frame: 35 days
To see if effects on bodyweight are associated with effects on fat mass, eating behaviour brain function and blood and urine markers
Time frame: 35 days
To see if effects on bodyweight correlate with over-eating behaviour at baseline
Time frame: 35 days
Safety: adverse events,blood pressure, heart rate, ECG, clinical chemistry, hematology, urinalysis, change in cognition (eg reaction times), change in mood scales, change in neuropsychiatric symptoms
Time frame: 35 days
Pharmacokinetic/Pharmacodynamic (PK/PD) relationships: effects on primary and secondary outcomes, including estimation of possible dose-response relationships
Time frame: 35 days
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