Research study to look at how well semaglutide works in people living with heart failure, obesity and type 2 diabetes

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 - STEP HFpEF DM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004170-22-DE

Enrollment

610

Registered

2021-03-08

Start date

2021-05-17

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure with preserved ejection fraction Diabetes Mellitus, type 2 MedDRA version: 20.1 Level: LLT Classification code 10076396 Term: Heart failure with preserved ejection fraction System Organ Class: 100000004849

Interventions

Product Name: Semaglutide D 0.5 mg/mL DV3396 Pharmaceutical Form: Solution for injection in pre-filled pen INN or Proposed INN: semaglutide CAS Number: 910463-68-2 Other descriptive name: SEMAGLUTIDE

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female, age above or equal to 18 years at the time of signing informed consent. - Body mass index (BMI) at least 30.0 kg/m^2 - New York Heart Association (NYHA) Class II-IV - Left ventricular ejection fraction (LVEF) at least 45% at screening - Diagnosed with T2D at least 90 days prior to the day of screening - HbA1c of maximum 10.0% as measured at the screening visit Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 305 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 305

Exclusion criteria

Exclusion criteria: - A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.;Secondary Objective: - To investigate the effects of semaglutide s.c. 2.4 mg once-weekly in improving the overall clinical benefit compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D. - To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on walking distance, biomarker of inflammation, disease specific aspects, social limitation, change in body composition, health-related quality of life, and glycaemic control and hypoglycaemia compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.;Primary end point(s): 1. Change in KCCQ clinical summary score 2. Change in body weight;Timepoint(s) of evaluation of this end point: 1.-2. From baseline (week 0) to end of treatment (week 52)	—

Measure

Time frame

Main Objective: To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.;Secondary Objective: - To investigate the effects of semaglutide s.c. 2.4 mg once-weekly in improving the overall clinical benefit compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D. - To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on walking distance, biomarker of inflammation, disease specific aspects, social limitation, change in body composition, health-related quality of life, and glycaemic control and hypoglycaemia compared with placebo, both added to standard of care, in subjects with obesity-related HFpEF and T2D.;Primary end point(s): 1. Change in KCCQ clinical summary score 2. Change in body weight;Timepoint(s) of evaluation of this end point: 1.-2. From baseline (week 0) to end of treatment (week 52)

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change in 6-minute walking distance 2. Hierarchical composite of: (a) Time to all-cause death (b) number of heart failure events requiring hospitalisation or urgent heart failure visit (c) time to first heart failure event requiring hospitalisation or urgent heart failure visit (d) difference at least 15 in KCCQ clinical summary score change from baseline to 52 weeks (e) difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks (f) difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks (g) difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio) 3. Change in C-Reactive Protein 4. Subject achieving 10% weight loss or more (Yes/No) 5. Subject achieving 15% weight loss or more (Yes/No) 6. Subject achieving 20 % weight loss or more (Yes/No) 7. Subject improving 5 points or more in KCCQ clinical summary score (Yes/No) 8. Subject improving 10 points or more in KCCQ clinical summary score (Yes/No) 9. Change in KCCQ overall summary score 10. Subject achieving threshold for clinically meaningful within-subject change in KCCQ-CSS 11. Subject achieving threshold for clinically meaningful within-subject change in 6MWD 12. Change in waist circumference 13. Change in systolic blood pressure 14. Change in HbA1c 15. Number of treatment emergent severe or clinically significant hypoglycaemia episodes;Timepoint(s) of evaluation of this end point: 1., 4.-12., 14. From baseline (week 0) to end of treatment (week 52) 2.,15. From baseline (week 0) to end of study (week 57) 3.,13. From baseline (week -2) to end of treatment (week 52)	—

Measure

Time frame

Secondary end point(s): 1. Change in 6-minute walking distance 2. Hierarchical composite of: (a) Time to all-cause death (b) number of heart failure events requiring hospitalisation or urgent heart failure visit (c) time to first heart failure event requiring hospitalisation or urgent heart failure visit (d) difference at least 15 in KCCQ clinical summary score change from baseline to 52 weeks (e) difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks (f) difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks (g) difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio) 3. Change in C-Reactive Protein 4. Subject achieving 10% weight loss or more (Yes/No) 5. Subject achieving 15% weight loss or more (Yes/No) 6. Subject achieving 20 % weight loss or more (Yes/No) 7. Subject improving 5 points or more in KCCQ clinical summary score (Yes/No) 8. Subject improving 10 points or more in KCCQ clinical summary score (Yes/No) 9. Change in KCCQ overall summary score 10. Subject achieving threshold for clinically meaningful within-subject change in KCCQ-CSS 11. Subject achieving threshold for clinically meaningful within-subject change in 6MWD 12. Change in waist circumference 13. Change in systolic blood pressure 14. Change in HbA1c 15. Number of treatment emergent severe or clinically significant hypoglycaemia episodes;Timepoint(s) of evaluation of this end point: 1., 4.-12., 14. From baseline (week 0) to end of treatment (week 52) 2.,15. From baseline (week 0) to end of study (week 57) 3.,13. From baseline (week -2) to end of treatment (week 52)

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Countries

Austria, Czech Republic, European Union, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden

Contacts

Public ContactClinical Transparency (2834)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026