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
ClinicalTrials.gov processed this data on March 14, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED (See Contacts and Locations)Verified March 2024 by Novo Nordisk A/S
Sponsor
Novo Nordisk A/SInformation Provided by (Responsible Party)
Novo Nordisk A/SClinicaltrials.gov Identifier
NCT04916470Other Study ID Numbers: EX9536-4773
First Submitted: June 1, 2021
First Posted: June 7, 2021
Last Update Posted: March 15, 2024
Last Verified: March 2024
History of Changes
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Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
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Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 610 participants |
| Design Allocation | Randomized |
| Interventional Model | Parallel Assignment |
| Masking | Quadruple |
| 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 |
| Study Start Date | June 15, 2021 |
| Actual Primary Completion Date | October 11, 2023 |
| Actual Study Completion Date | October 11, 2023 |
Groups and Cohorts
| Group/ Cohort | Intervention/ Treatment |
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Outcome Measures
Primary Outcome Measures
- Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score [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.
- Change in body weight [From baseline (week 0) to end of treatment (week 52)] Percentage (%)
Secondary Outcome Measures
- Change in 6-minute walking distance [From baseline (week 0) to end of treatment (week 52)] Measured in metres
- Hierarchical composite of time to all-cause death [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 [From baseline (week 0) to end of study (week 57)] Measured as total wins for each treatment group
- Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit [From baseline (week 0) to end of study (week 57)] Measured as total wins for each treatment group.
- Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score change from baseline to 52 weeks [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 [From baseline (week 0) to end of study (week 57)] Measured as total wins for each treatment group.
- Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks [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) [From baseline (week 0) to end of study (week 57)] Measured as total wins for each treatment group.
- Change in C-Reactive Protein [From baseline (week -2) to end of treatment (week 52)] Presented as ratio to baseline
- Participant achieving 10% weight loss or more (Yes/No) [From baseline (week 0) to end of treatment (week 52)] Count of participants
- Participant achieving 15% weight loss or more (Yes/No) [From baseline (week 0) to end of treatment (week 52)] Count of participants
- Participant achieving 20% weight loss or more (Yes/No) [From baseline (week 0) to end of treatment (week 52)] Count of participants
- Participant improving 5 points or more in KCCQ clinical summary score [From baseline (week 0) to end of treatment (week 52)] Count of participants
- Participant improving 10 points or more in KCCQ clinical summary score (Yes/No) [From baseline (week 0) to end of treatment (week 52)] Count of participants
- Change in KCCQ overall summary score [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.
- Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS [From baseline (week 0) to end of treatment (week 52)] Count of participants
- Participant achieving threshold for clinically meaningful within-subject change in 6MWD [From baseline (week 0) to end of treatment (week 52)] Count of participants
- Change in waist circumference [From baseline (week 0) to end of treatment (visit 52)] Measured in centimetre (cm)
- Change in systolic blood pressure [From baseline (week -2) to end of treatment (week 52)] Measured in millimetre of mercury (mmHg)
- Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 52)] Measured in percentage (%)-point
- Number of treatment emergent severe or clinically significant hypoglycaemia episodes [From baseline (week 0) to end of trial (week 57)] Count of events
Eligibility Criteria
| Ages Eligible for Study | 18 Years and Older (Adult, Older Adult) |
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| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
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| Exclusion Criteria |
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Contacts and Locations
| Sponsors and Collaborators | Novo Nordisk A/S |
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| Locations |
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| Investigators |
More Information
Publications
Additional Relevant MeSH Terms
- Heart Failure
- Diabetes Mellitus
- Diabetes Mellitus, Type 2
- Glucose Metabolism Disorders
- Metabolic Diseases
- Endocrine System Diseases
- Heart Diseases
- Cardiovascular Diseases