4665: Semaglutide in Heart Failure with Preserved Ejection Fraction

• 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

• IRAS ID

  290920

• Contact name

  Karen Griffiths

• Contact email

  nn-ct-approvals@novonordisk.com

• Sponsor organisation

  Novo Nordisk

• Eudract number

  2019-004452-11

• Clinicaltrials.gov Identifier

  NCT04788511

• Clinicaltrials.gov Identifier

  Universal Trial Number, U1111-1243-4358

• Duration of Study in the UK

  2 years, 1 months, 24 days

• Research summary

  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 and 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).

  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 59 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 11 clinic visits and one phone call during the course of the study. The study plan is to include a total of 516 participants across 13 countries including the UK. In the UK, the planned number of participants is 45.

  LAY SUMMARY OF RESULTS:
  The researchers found that people treated with semaglutide reduced their body weight more and had less heart failure symptoms compared with people treated with dummy medicine. It also improved walk distance, blood pressure and waist size compared to dummy medicine. This improved the quality of life of the people with excess body weight.
  Semaglutide was well received by the people in the study, and no new safety concerns were seen.
  More details on this study can be found on the website https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novonordisk-trials.com%2F&data=05%7C02%7Ccoventryandwarwick.rec%40hra.nhs.uk%7C3a145b7268494ec8e1fd08dbfd682ced%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638382396096455798%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C3000%7C%7C%7C&sdata=sTAlWJDqwp4qsbwrIGOND1HGRftPmwXqliTuQG9Z%2Ftc%3D&reserved=0 EX9536-4665

  https://www.clinicaltrialsregister.eu/ctr-search/search?query=2019-004452-11

• REC name

  West Midlands - Coventry & Warwickshire Research Ethics Committee

• REC reference

  20/WM/0313

• Date of REC Opinion

  6 Jan 2021

• REC opinion

  Further Information Favourable Opinion