4773: Semaglutide in HFpEF and T2DM
Research type
Research Study
Full title
Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction, and type 2 diabetes
IRAS ID
294855
Contact name
Mark Petrie
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2020-004170-22
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
Universal Trial Number, U1111-1257-5069
Duration of Study in the UK
2 years, 1 months, 24 days
Research summary
The STEP HFpEF study (EX9536-4665) has been designed to test the effects of treatment with a glucagon like peptide 1 receptor agonist (GLP1-RA) called semaglutide on symptoms, physical function, quality of life, and weight-loss in a
population with obesity-related heart failure with preserved ejection fraction (HFpEF: a disorder where the heart is able pump the blood out but is not able to relax enough to fill back up) and type 2 diabetes.Eligible participants will randomly be assigned to receive either semaglutide 2.4mg per week or placebo as an add-on to standard of care in a 1:1 ratio and the treatment is expected to last 52 weeks. 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 12 clinic visits during the course of the study. The study plan is to include a total of 610 participants across 15 countries including the UK. In the UK, the planned number of participants is 40.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0073
Date of REC Opinion
22 Mar 2021
REC opinion
Favourable Opinion