ELIOT (Effect of Liraglutide in Obesity Treatment)- General

• Research type

  Research Study

• Full title

  Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with co-morbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either one or three years of treatment based on pre-diabetes status at randomisation.

• IRAS ID

  7763

• Sponsor organisation

  Novo Nordisk

• Eudract number

  2008-001049-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of this study is to investigate the effect of liraglutide with a structured diet and exercise programme in safely inducing long term weight loss in non-diabetic overweight or obese patients. The study will also investigate the potential of liraglutide to prevent the development of diabetes in patients at high risk of developing this disease. Liraglutide is a modified form of a naturally-occurring hormone called GLP-1 (glucagon-like peptide 1). GLP-1 is produced in the gut after eating a meal and has several effects on the body, one of which is to slow down the passage of food through the gut leading to an increased feeling of fullness. Previous studies with liraglutide have shown that it causes increased weight loss by reducing the amount of food that you eat. Subjects included in the study will receive either active liragutide (approximately 2 in 3 chance) or liraglutide placebo (1 in 3 chance). To avoid bias, neither the study doctor nor the subject will know which treatment the subject is receiving (double-blind).Liraglutide is a liquid which is administered by an injection under the skin (subcutaneous). It will be provided to patients in an injection pen (FlexPen©). Subjects will also be asked to undertake a calorie controlled diet and will be given dietary and lifestyle counselling throughout the study. A planned total of 3,600 patients will take part in the study from 27 different countries worldwide. The majority of patients will be asked to attend a total of 21 visits over period of 66 weeks. This will include a screening period of 2 weeks, a treatment period of 52 weeks and follow-up of 12 weeks. A proportion (600) of patients who are thought to be at high risk of developing diabetes (pre-diabetes) will take part in a longer study for 3 years with a total of 45 clinic visits.

• REC name

  West of Scotland REC 1

• REC reference

  08/S0703/171

• Date of REC Opinion

  14 Jan 2009

• REC opinion

  Further Information Favourable Opinion