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Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes (STEP HFpEF DM)

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ClinicalTrials.gov Identifier: NCT04916470
Recruitment Status : Completed
First Posted : June 7, 2021
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight.

This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms.

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 and physical activity.

The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor.

  • At 6 of the visits participants will have blood samples taken.
  • At 5 of the visits participants will be asked to fill in a questionnaire
  • At 4 of the visits participants will have to do a 6-minute walking test
  • At 3 of the visits participants will have a test to check the heart.
  • participants will have their eyes checked before or at the start of the study and at the end of the study

Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.


Condition or disease Intervention/treatment Phase
Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2 Drug: Semaglutide Drug: Placebo (Semaglutide) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 610 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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, and Type 2 Diabetes
Actual Study Start Date : June 15, 2021
Actual Primary Completion Date : October 11, 2023
Actual Study Completion Date : October 11, 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 2.4 mg once weekly (OW)
Participants will receive semaglutide injections for 52 weeks.
 Drug: Semaglutide
Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.
Placebo Comparator: Semaglutide placebo OW
Participants will receive semaglutide placebo injections for 52 weeks.
 Drug: Placebo (Semaglutide)
Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 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 on a scale of 0 to 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 6-minute walking distance [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Measured in 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. Hierarchical 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. Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (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) ]
    Measured as 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 [ Time Frame: From baseline (week -2) to end of treatment (week 52) ]
    Presented as ratio to baseline

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

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

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

  13. Participant improving 5 points or more in KCCQ clinical summary score [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Count of participants

  14. Participant 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 participants

  15. Change in KCCQ overall summary score [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.

  16. Participant 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 participants

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

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

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

  20. Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]
    Measured in percentage (%)-point

  21. Number of treatment emergent severe or clinically significant hypoglycaemia episodes [ Time Frame: From baseline (week 0) to end of trial (week 57) ]
    Count of events


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% at screening
  • Diagnosed with T2D greater than or equal to 90 days prior to the day of screening
  • HbA1c of below or equal to 10.0% as measured at the screening visit

Exclusion Criteria:

  • A self-reported change in body weight greater 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.
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): NCT04916470


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:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04916470    
Other Study ID Numbers: EX9536-4773
U1111-1257-5069 ( Other Identifier: World Health Organization (WHO) )
2020-004170-22 ( EudraCT Number )
First Posted: June 7, 2021    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
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
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Heart Diseases
Cardiovascular Diseases
Semaglutide
Glucagon-Like Peptide-1 Receptor Agonists
Hypoglycemic Agents
Physiological Effects of Drugs