4153: Once Daily Semaglutide in Obese Subjects without DM
Research type
Research Study
Full title
Investigation of safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus. A 52-week, randomised, double-blind, placebo-controlled, nine-armed, parallel group, multi centre, multinational trial with liraglutide 3.0 mg as active comparator.
IRAS ID
182784
Contact name
John Wilding
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2014-001540-38
Duration of Study in the UK
1 years, 6 months, 20 days
Research summary
NN9536-4153 is a 52-week, multicentre, randomised, double-blind study investigating the potential of semaglutide at five dose levels to induce weight loss in obese subjects without diabetes compared to placebo and liraglutide 3.0mg.
The study duration is approximately 60 weeks, consisting of a screening period of up to 2 weeks, a 52 week treatment period and a 7 week follow up period. If eligible, participants will be randomised into either one of five different target doses of daily semaglutide (0.05mg, 0.1mg, 0.2mg, 0.3mg or 0.4mg) or liraglutide 3.0mg or placebo. To maintain the study blind every treatment arm will have a corresponding placebo arm. The treatment allocation is made in a 6:1 manner, for every 6 participants on active treatment (Semaglutide or Liraglutide) there will be one participant on placebo. There will be a dose escalation period until the target dose is reached. Furthermore a fast escalation regimen will be investigated to explore if the target doses in the semaglutide group can be reached earlier whilst still being tolerated by the participants. All treatments are administered once daily by subcutaneous injection.
The study consists of up to 21 clinic visits. The study plan is to include a total of 935 randomised subjects across 8 countries including the UK. In the UK, the planned number of randomised subjects is 113 across a possible 8 sites.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
15/WM/0238
Date of REC Opinion
13 Aug 2015
REC opinion
Further Information Favourable Opinion