STEP 1 - Semaglutide Treatment Effect in People with obesity
Research type
Research Study
Full title
Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity
IRAS ID
242180
Contact name
Lucy Clemente
Contact email
Sponsor organisation
Novo Nordisk
Eudract number
2017-003436-36
Clinicaltrials.gov Identifier
U1111-1200-8053, Universal Trial Number
Duration of Study in the UK
1 years, 10 months, 17 days
Research summary
The STEP 1 study (NN9536-4373) is a 68-week, multicentre, randomised, double-blind, placebo-controlled study comparing the effect of semaglutide versus placebo as an add-on to a reduced calorie diet and increased physical activity on body weight in participants who are overweight or have obesity.
The study duration is approximately 76 weeks, consisting of a screening period of 1 week, a 68 week treatment period and a 7 week follow up period.
If eligible, participants will be randomised to receive either weekly doses of 2.4 mg Semaglutide or placebo. In addition all trial participants will also receive diet and physical activity counselling. Neither the participant nor the study doctor will know what treatment the participant is assigned to. The treatment allocation is made in a 2:1 manner, for every two participants on active treatment (Semaglutide) there will be one participant on placebo. There will be a dose escalation period until the target dose of 2.4 mg weekly is reached. All treatments are administered once weekly by subcutaneous (under the skin) injection.
The study consists of up to 15 clinic visits and 10 phone calls. The study plan is to include a total of randomised subjects 1950 across 9 countries including the UK. In the UK, the planned number of randomised subjects is 215 across a possible 10 sites.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0172
Date of REC Opinion
17 May 2018
REC opinion
Further Information Favourable Opinion