Clinical Trial: A 35 Day Study to Investigate the Effects of GSK1521498 on Bodyweight in Obese Subjects With Over-Eating Behaviours.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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 an

Brief Summary: The purpose of this study is to determine whether GSK1521498 will cause weight loss in obese but otherwise healthy subjects with over-eating behaviours.

Detailed Summary: 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.
Sponsor: GlaxoSmithKline

Current Primary Outcome: Clinically and statistically significant weight loss [ Time Frame: 35 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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, heamatology, urinalysis, change in cognition (eg reaction times), change in mood scales, change in neuropsychiatric symptoms [ Time Frame: 35 days ]
  • PK/PD relationships: effects on primary and secondary outcomes, including estimation of possible dose-response relationships [ Time Frame: 35 days ]


Information By: GlaxoSmithKline

Dates:
Date Received: September 3, 2010
Date Started: September 2010
Date Completion:
Last Updated: November 30, 2016
Last Verified: November 2016