Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity (STEP-HFpEF)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04788511 |
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Recruitment Status :
Completed
First Posted : March 9, 2021
Last Update Posted : May 18, 2023
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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 Type : | Interventional (Clinical Trial) |
| Actual 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 |
| Actual Primary Completion Date : | April 18, 2023 |
| Actual Study Completion Date : | April 18, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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. |
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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.
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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. |
- 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)
- Change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 52) ]Percentage
- Change in six-minute walking distance [ Time Frame: From baseline (week 0) to end of treatment (week 52 ]Metres
- 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
- 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.
- 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.
- 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
- 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.
- 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
- 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
- Change in C-Reactive Protein (CRP) [ Time Frame: From baseline (week -2) to end of treatment (week 52) ]Ratio to baseline (no unit)
- 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
- 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
- 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
- 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
- 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
- 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)
- 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
- 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
- Change in systolic blood pressure (SBP) [ Time Frame: From baseline (week -2) to end of treatment (week 52) ]mmHg
- Change in waist circumference [ Time Frame: From baseline (week 0) to end of treatment (visit 52) ]cm
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
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| Study Director: | Clinical Transparency (dept. 1452) | Novo Nordisk A/S |
| 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: | May 18, 2023 |
| Last Verified: | May 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Heart Failure Obesity Overweight Overnutrition |
Nutrition Disorders Body Weight Heart Diseases Cardiovascular Diseases |