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Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity (STEP-HFpEF)

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ClinicalTrials.gov Identifier: NCT04788511
Recruitment Status : Completed
First Posted : March 9, 2021
Last Update Posted : September 11, 2023
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine.

Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.

During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity.

The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.


Condition or disease Intervention/treatment Phase
Obesity Drug: Semaglutide Drug: Placebo (semaglutide) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 529 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose: Treatment
Official Title: Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction
Actual Study Start Date : March 16, 2021
Actual Primary Completion Date : April 18, 2023
Actual Study Completion Date : April 18, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
 Drug: Semaglutide

Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.

Dose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks.
Placebo Comparator: Placebo (semaglutide)
All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
 Drug: Placebo (semaglutide)

Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.

The study will last for approximately 59 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in KCCQ (Kansas City Cardiomyopathy Questionnaire ) clinical summary score [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)

  2. Change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Percentage


Secondary Outcome Measures :
  1. Change in six-minute walking distance [ Time Frame: From baseline (week 0) to end of treatment (week 52 ]
    Metres

  2. Hierarchical composite of time to all-cause death [ Time Frame: From baseline (week 0) to end of study (week 57) ]
    Measured as total wins for each treatment group

  3. Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit [ Time Frame: From baseline (week 0) to end of study (week 57) ]
    Measured as total wins for each treatment group.

  4. Hierarchial composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit [ Time Frame: From baseline (week 0) to end of study (week 57) ]
    Measured as total wins for each treatment group.

  5. Hierarchial composite of difference at least 15 in KCCQ clinical summary score change from baseline to 52 weeks [ Time Frame: From baseline (week 0) to end of study (week 57) ]
    Measured as total wins for each treatment group

  6. Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks [ Time Frame: From baseline (week 0) to end of study (week 57) ]
    Total wins for each treatment group.

  7. Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks [ Time Frame: From baseline (week 0) to end of study (week 57) ]
    Measured as total wins for each treatment group

  8. Hierarchical composite of difference at least 30 metres in six minute walking distance change from baseline to 52 weeks (assessed by the win ratio) [ Time Frame: From baseline (week 0) to end of study (week 57) ]
    Measured as total wins for each treatment group

  9. Change in C-Reactive Protein (CRP) [ Time Frame: From baseline (week -2) to end of treatment (week 52) ]
    Ratio to baseline (no unit)

  10. Subject achieving 10 percentage weight loss or more (Yes/No) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of subjects

  11. Subject achieving 15 percentage weight loss or more (Yes/No) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of subjects

  12. Subject achieving 20 percentage weight loss or more (Yes/No) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of subjects

  13. Subject improving 5 points or more in KCCQ clinical summary score (Yes/No) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of subjects

  14. Subject improving 10 points or more in KCCQ clinical summary score (Yes/No) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of subjects

  15. Change in KCCQ overall summary score [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Score (no unit, range; 0-100 where the score 100 means the least burden for the participant)

  16. Subject achieving threshold for clinically meaningful within-subject change in KCCQ-CSS [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of subjects

  17. Subject achieving threshold for clinically meaningful within-subject change in 6MWD [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of subjects

  18. Change in systolic blood pressure (SBP) [ Time Frame: From baseline (week -2) to end of treatment (week 52) ]
    mmHg

  19. Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (visit 52) ]
    cm


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Body mass index (BMI) greater than or equal to 30.0 kg/m^2
  • New York Heart Association (NYHA) Class II-IV
  • Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
  • Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04788511


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04788511    
Other Study ID Numbers: EX9536-4665
U1111-1243-4358 ( Other Identifier: World Health Organization (WHO) )
2019-004452-11 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Failure
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
 Heart Diseases
Cardiovascular Diseases
Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs