Research study to investigate how well semaglutide works in people living with obesity and heart failure

Effect of semaglutide 2.4 mg once weekly on function and symptoms in subjects with obesity-related heart failure with preserved ejection fraction - STEP-HFpEF

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004452-11-HU

Enrollment

516

Registered

2020-11-20

Start date

2021-01-12

Completion date

Unknown

Last updated

2021-04-05

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 Obesity 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 2.0 mg/ml DV3396 Pharmaceutical Form: Solution for injection INN or Proposed INN: semaglutide CAS Number: 910463-68-2 Other descriptive name: SEMAGLUTIDE Concentration unit

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) equal to or above 30.0 kg/m^2 - New York Heart Association (NYHA) Class II-IV - Left ventricular ejection fraction (LVEF) equal to or above 45 % at screening 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 258 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 258

Exclusion criteria

Exclusion criteria: - A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records - Glycated haemoglobin A1c (HbA1c) equal to or above 6.5 % (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of 2.4 mg semaglutide administered subcutaneously (s.c. under the skin) once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity related heart failure with preserved ejection fraction (HFpEF);Secondary Objective: To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on walking distance, biomarker of inflammation, body composition, disease specific aspects, social limitation, and health-related quality of life compared with placebo, both added to standard of care, in subjects with obesity related HFpEF.;Primary end point(s): 1. Change in Kansas City Cardiomyopathy Questionnaire (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 2.4 mg semaglutide administered subcutaneously (s.c. under the skin) once-weekly on physical function, symptoms and body weight compared with placebo, both added to standard of care, in subjects with obesity related heart failure with preserved ejection fraction (HFpEF);Secondary Objective: To investigate the effects of semaglutide s.c. 2.4 mg once-weekly on walking distance, biomarker of inflammation, body composition, disease specific aspects, social limitation, and health-related quality of life compared with placebo, both added to standard of care, in subjects with obesity related HFpEF.;Primary end point(s): 1. Change in Kansas City Cardiomyopathy Questionnaire (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 C-Reactive Protein (CRP) 2. Change in 6 minutes walking distance 3. Subject achieving 10 % weight loss or more (Yes/No) 4. Subject achieving 15 % weight loss or more (Yes/No) 5. Subject improving 5 points or more in KCCQ clinical summary score (Yes/No) 6. Subject improving 10 points or more in KCCQ clinical summary score (Yes/No) 7. Change in KCCQ overall summary score 8. Change in systolic blood pressure (SBP) 9. Change in waist circumference;Timepoint(s) of evaluation of this end point: 1. From baseline (week -2) to end of treatment (week 52) 2. – 7. From baseline (week 0) to end of treatment (week 52) 8. From baseline (week -2) to end of treatment (week 52) 9. From baseline (week 0) to end of treatment (week 52)	—

Measure

Time frame

Secondary end point(s): 1. Change in C-Reactive Protein (CRP) 2. Change in 6 minutes walking distance 3. Subject achieving 10 % weight loss or more (Yes/No) 4. Subject achieving 15 % weight loss or more (Yes/No) 5. Subject improving 5 points or more in KCCQ clinical summary score (Yes/No) 6. Subject improving 10 points or more in KCCQ clinical summary score (Yes/No) 7. Change in KCCQ overall summary score 8. Change in systolic blood pressure (SBP) 9. Change in waist circumference;Timepoint(s) of evaluation of this end point: 1. From baseline (week -2) to end of treatment (week 52) 2. – 7. From baseline (week 0) to end of treatment (week 52) 8. From baseline (week -2) to end of treatment (week 52) 9. From baseline (week 0) to end of treatment (week 52)

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Countries

Argentina, Australia, Canada, European Union, Germany, Hungary, Israel, Netherlands, United Kingdom, United States

Contacts

Public ContactClinical Transparency (1452)

Novo Nordisk A/S

clinicaltrials@novonordisk.com

Outcome results

None listed

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