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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 : Recruiting
First Posted : March 9, 2021
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 516 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
Estimated Primary Completion Date : March 15, 2023
Estimated Study Completion Date : April 25, 2023

Resource links provided by the National Library of Medicine

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

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.





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

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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

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

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



Information from the National Library of Medicine

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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

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


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

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
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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: June 11, 2021
Last Verified: June 2021
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
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Heart Diseases
Cardiovascular Diseases