EX9536-4388 SELECT semaglutide cardiovascular outcome trial
Research type
Research Study
Full title
SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity
IRAS ID
249725
Contact name
John Wilding
Contact email
Sponsor organisation
Novo Nordisk
Eudract number
2017-003380-35
Clinicaltrials.gov Identifier
U1111-1200-5564, Universal Trial Number:
Duration of Study in the UK
4 years, 10 months, 18 days
Research summary
The SELECT study (EX9536-4388) has been designed to test the effects of treatment with a Glucagon like peptide 1 receptor agonist (GLP1 - RA) called Semaglutide on cardiovascular outcomes in people with overweight or obesity who are at increased risk of cardiovascular disease.
Eligible participants will randomly be assigned to receive either Semaglutide 2.4mg per week or placebo in a 1:1 ratio and the treatment is expected to last between 31 and 59 months. There will be a dose escalation period of around 16 weeks until the target dose is reached. All treatments are administered once weekly by subcutaneous (under the skin) injection.
Participants will be asked to attend up to approximately 25 clinic visits and one phone call during the course of the study. The study plan is to include a total of 17,500 participants across 40 countries including the UK. In the UK, the planned number of participants is 1000.REC name
North West - Haydock Research Ethics Committee
REC reference
18/NW/0514
Date of REC Opinion
13 Jul 2018
REC opinion
Favourable Opinion