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 October 8, 2024. Link to the current ClinicalTrials.gov record.Recruitment Status
COMPLETED (See Contacts and Locations)Verified October 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: October 9, 2024
Last Verified: October 2024
History of Changes
Disclaimer
Listing a study on this site does not mean it has been evaluated by the U.S. Federal Government. The safety and scientific validity of a study listed on ClinicalTrials.gov is the responsibility of the study sponsor and investigators. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
ClinicalTrials.gov, a resource provided by the U.S. National Library of Medicine (NLM), is a registry and results information database of clinical research studies sponsored or funded by a broad range of public and private organizations around the world. Not all studies listed on ClinicalTrials.gov are funded by the National Institutes of Health (NIH) or other agencies of the U.S. Federal Government. Not all listed studies are regulated and/or reviewed by the U.S. Food and Drug Administration or other governmental entities.
Information on ClinicalTrials.gov is provided by study sponsors and investigators, and they are responsible for ensuring that the studies follow all applicable laws and regulations. NLM staff do not verify the scientific validity or relevance of the submitted information beyond a limited quality control review for apparent errors, deficiencies, or inconsistencies.
Choosing to participate in a study is an important personal decision. Before you participate in a study, discuss all options with your health care provider and other trusted advisors. For more information about participating in clinical studies, see Learn About Clinical Studies, which includes questions that you might want to ask before deciding to participate in a study.
For more information about using the information on ClinicalTrials.gov, please also see Terms and Conditions.
See also the Web Policies and Notices for the NIH web site.
Study Description
Not Provided| Condition or Disease | Intervention/Treatment |
|---|---|
|
|
Study Design
| Study Type | Interventional |
|---|---|
| Actual Enrollment | 617 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 |
|---|---|
|
|
|
|
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) |
|---|---|
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | No |
| Inclusion Criteria |
|
| Exclusion Criteria |
|
Contacts and Locations
| Sponsors and Collaborators | Novo Nordisk A/S |
|---|---|
| Locations |
|
| 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