Randomised,multiple dose, two period crossover study in Obese Subjects
Research type
Research Study
Full title
A single-centre, randomised, double-blind two-period cross-over trial investigating the effect of semaglutide on energy intake, appetite sensations, postprandial glucose and triglyceride metabolism and gastric emptying in obese subjects compared with placebo
IRAS ID
144882
Contact name
Ashley Brooks
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2013-000012-24
ISRCTN Number
n/a
Research summary
This study is being performed to assess a new medication currently being developed for the treatment of Type 2 diabetes. The Study drug is chemically comparable to and has a similar effect to a hormone already found in the body called GLP-1 (human glucagon-like peptide-1). The Study drug stimulates insulin secretion in patients with high glucose levels and therefore helps glucose return to normal levels.
It is known that the study drug and other similar drugs, in addition to their effect on glucose levels, have the potential to decrease energy intake due to a decreased appetite. The exact reason for the decreased appetite is not fully known therefore the main aim of this study is to investigate the effect of the study drug on food intake, appetite and food preference.This is a multiple dose, randomised study where obese subjects will participate in two treatment periods. In one treatment period they will receive the study drug and in the other they will receive placebo. In addition to the effect on food intake, appetite and food preference, the study will also look into the changes in blood glucose (sugar) and triglycerides (a type of fat found in the blood) following a meal as well as the emptying of the stomach after a meal.
In total 30 obese male and female subjects will be dosed on this study.REC name
North East - York Research Ethics Committee
REC reference
14/NE/0008
Date of REC Opinion
3 Feb 2014
REC opinion
Further Information Favourable Opinion