Proof of Concept Study for GSK1521498 in Obese Subjects

• Research type

  Research Study

• Full title

  A 35-Day, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Placebo-Controlled Proof of Concept Study to Investigate the Effects of GSK1521498 on Body Weight and Composition, Eating Behaviour and Related Brain Function, in Obese Subjects with Over-Eating Behaviours.

• IRAS ID

  56634

• Contact name

  Annelize Koch

• Sponsor organisation

  GlaxoSmithKline

• Eudract number

  2009-016663-11

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  An uncontrollable urge to eat high sugar or high fat foods is often a key component of obesity. The body naturally produces substances (opioids) that increase pleasurable responses to eating these foods. The drug we are testing binds to specific sites in the brain, known as mu-opioid receptors. This may block the effect of opioids, and therefore the pleasure response. This in turn may interfere with eating behaviour and help obese patients to lose weight.This is the fourth study where this drug will be given to human participants. The study will involve 35 days of taking study medication. Participants will receive one of 2 dose strengths (2mg or 5mg) of study drug and / or placebo during the 35 days. This study consists of one 3-night stay and up to two 2-night stays at the GSK Clinical Unit Cambridge (CUC) and three five short day visits to subject??s recruitment centres (CUC, London or Birmingham) while taking medication every morning for the duration of the study. We will measure blood levels of the drug and test its effects on mood, cognition (mental processes involved in awareness, learning and judgement), eating behaviour, food intake, weight, waist/hip measurements and body composition.Approximately 60 participants (men and women) will be enrolled to ensure 60 participants complete the study.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  10/H0505/68

• Date of REC Opinion

  27 Aug 2010

• REC opinion

  Further Information Favourable Opinion