Obesity Clinical Trial
Official title:
A Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of 10 Days of Repeat Dosing of GSK1521498 in Overweight or Obese But Otherwise Healthy Subjects.
The overall purpose of this study is to see whether the drug is safe and well tolerated when given to overweight or obese but otherwise healthy volunteers for 10 days. Up to 4 groups of people will be given the drug at variable strengths. The blood levels of the drug will be measured and the effects on mood and cognition (the mental processes involved in awareness, learning and judgement) will be assesed.
This study is to test a new drug which may be used for treating eating behaviour and
patterns that some overweight and obese patients find difficult to control. The drug works
by inhibiting the effects of messenger molecules called opioids, e.g. endorphins. These
opioids are naturally produced within the human body and control hunger, thirst, and the
pleasurable feelings we relate to eating food. The drug attaches to opioid binding sites in
the brain, known as mu-opioid receptors; this blocks the natural effect of opioids which may
reduce the craving to eat fatty or sugary foods. Single doses of the drug have been given to
humans and showed it was safe. Now the drug will be given every day for 10 days to check
that the drug is safe and tolerated when given repeatedly. The study is in two parts:
Part A: people will receive a sleeping tablet to make them sleepy (or a dummy drug) and will
complete some questionnaires and simple tests including computer exercises to test the
effect of this tablet on mood and cognition. This information will be used to help judge
what is happening in Part B.
Part B: requires staying in the unit for 10 days to receive a tablet every day and complete
questionnaires and other tests to check for any mood and cognitive changes. Various other
assessments will include effects on eating behaviour, pain measures and changes in body
composition (content of fat, muscle and water).
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