4734 STEP10 semaglutide s.c.in subjects with obesity and prediabetes
Research type
Research Study
Full title
Efficacy and safety of subcutaneous semaglutide 2.4 mg once-weekly in subjects with obesity and prediabetes
IRAS ID
298529
Contact name
Harpal Randeva
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2020-002939-29
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Universal Trial Number, U1111-1253-1956
Duration of Study in the UK
1 years, 10 months, 19 days
Research summary
Summary of Research
The STEP 10 study (NN9536-4734) is a 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 with both obesity and prediabetes. The study is divided in a main and an extension phase.
The study consists of a screening period of 2 weeks, a 52-week treatment period and a 5-week follow up period for the main phase; and a 28-week off-treatment period for the extension phase. The study duration for the main and extension phases is approximately 82 weeks;
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 12 clinic visits and 1 phone call for the main phase; and 2 clinic visits for the extension phase. The study plan is to include a total of randomised subjects 201 across 5 countries including the UK. In the UK, the planned number of randomised subjects is 44 across a possible 8 sites.Summary of Research
The researchers looked at the change in initial body weight (body weight of people at the study start, week 0) after taking the study medicine for 52 weeks.
The researchers found that semaglutide 2.4 mg worked better than placebo in lowering the body weight and reducing blood sugar levels in people with excess body weight and with blood sugar levels slightly above normal level (prediabetes).
The results from this study also showed that semaglutide 2.4 mg was better than placebo in reducing waist measurement, lowering blood pressure, and improving lipid levels in the blood stream.
Semaglutide 2.4 mg was found to be well tolerated by the people involved in the study and no new safety concerns were seen.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
21/YH/0097
Date of REC Opinion
4 Jun 2021
REC opinion
Further Information Favourable Opinion