STEP 2 - Semaglutide Treatment Effect in People with obesity and T2DM
Research type
Research Study
Full title
Effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity and type 2 diabetes
IRAS ID
242176
Contact name
Nicole Griffiths
Contact email
Sponsor organisation
Novo Nordisk Limited
Eudract number
2017-003414-10
Clinicaltrials.gov Identifier
U1111-1200-8148, Universal Trial Number
Duration of Study in the UK
1 years, 11 months, 1 days
Research summary
The STEP 2 study (protocol number NN9536-4374) is a 68-week, randomised, double blind, double dummy, placebo-controlled, multi-centre 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 subjects who are overweight or have obesity and type 2 diabetes mellitus.
The study duration is approximately 76 weeks, consisting of a screening period of up to 1 week, a treatment period of 68 weeks and a follow-up period of 7 weeks.
If eligible, participants will be randomised to receive either semaglutide 2.4mg, semaglutide 1.0mg or placebo once-weekly. To maintain the study blind every treatment arm will have a corresponding placebo arm. The treatment allocation is made in a 1:1:1 manner meaning that there will be an equal distribution of patients in the three treatment groups. There will be a dose escalation period until the target dose is reached. All treatments are administered once weekly by subcutaneous (under the skin) injection.
Participants will be asked to attend 14 clinic visits and have 11 phone visits during the course of the study. The study plan is to include a total of 1200 participants across 13 countries including the UK. In the UK, the planned number of participants is 80.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
18/NW/0173
Date of REC Opinion
9 May 2018
REC opinion
Further Information Favourable Opinion