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/S

Information Provided by (Responsible Party)

Novo Nordisk A/S

Clinicaltrials.gov Identifier

NCT04916470
Other 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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Tracking Information
First Submitted DateJune 1, 2021
First Posted DateJune 7, 2021
Last Update Posted DateMarch 15, 2024
Study Start DateJune 15, 2021
Actual Primary Completion DateOctober 11, 2023
Current Primary Outcome Measures
(submitted: March 14, 2024)
  1. 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.
  2. Change in body weight [From baseline (week 0) to end of treatment (week 52)]
    Percentage (%)
Change HistoryComplete list of historical versions of study NCT04916470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
  1. Change in 6-minute walking distance [From baseline (week 0) to end of treatment (week 52)]
    Measured in metres
  2. 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.
  3. 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
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  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) [From baseline (week 0) to end of study (week 57)]
    Measured as total wins for each treatment group.
  9. Change in C-Reactive Protein [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) [From baseline (week 0) to end of treatment (week 52)]
    Count of participants
  11. Participant achieving 15% weight loss or more (Yes/No) [From baseline (week 0) to end of treatment (week 52)]
    Count of participants
  12. Participant achieving 20% weight loss or more (Yes/No) [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 [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) [From baseline (week 0) to end of treatment (week 52)]
    Count of participants
  15. 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.
  16. 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
  17. Participant achieving threshold for clinically meaningful within-subject change in 6MWD [From baseline (week 0) to end of treatment (week 52)]
    Count of participants
  18. Change in waist circumference [From baseline (week 0) to end of treatment (visit 52)]
    Measured in centimetre (cm)
  19. Change in systolic blood pressure [From baseline (week -2) to end of treatment (week 52)]
    Measured in millimetre of mercury (mmHg)
  20. Change in glycated haemoglobin (HbA1c) [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 [From baseline (week 0) to end of trial (week 57)]
    Count of events
Current Other Outcome MeasuresNot Provided
Descriptive Information
Brief TitleResearch Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes
Official TitleEffect 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
Brief SummaryThis 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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple
Primary Purpose: Treatment
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNot Provided
Study PopulationNot Provided
Condition
  • Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2
Intervention

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.

Study Groups/Cohorts

Experimental: Semaglutide 2.4 mg once weekly (OW)
Participants will receive semaglutide injections for 52 weeks.

Intervention:
  • Drug: Semaglutide

Placebo Comparator: Semaglutide placebo OW
Participants will receive semaglutide placebo injections for 52 weeks.

Intervention:
  • Drug: Placebo (Semaglutide)
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment
(submitted: March 14, 2024)		610
Actual Study Completion DateOctober 11, 2023
Actual Primary Study Completion DateOctober 11, 2023
Eligibility 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.

Sex/GenderSexes Eligible for Study: All
Ages18 Years and Older (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesUnited States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, United States, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Argentina, Austria, Austria, Austria, Austria, Austria, Canada, Canada, Canada, Canada, Canada, Canada, Czechia, Czechia, Czechia, Czechia, Czechia, Germany, Germany, Germany, Germany, Germany, Germany, Germany, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, Hungary, India, India, India, India, India, India, India, India, India, India, India, India, India, Israel, Israel, Israel, Israel, Israel, Italy, Italy, Italy, Italy, Italy, Italy, Japan, Japan, Japan, Japan, Japan, Japan, Netherlands, Netherlands, Netherlands, Netherlands, Netherlands, Poland, Poland, Poland, Poland, Poland, Poland, Spain, Spain, Spain, Sweden, Sweden, United Kingdom, United Kingdom, United Kingdom, United Kingdom, United Kingdom, United Kingdom, United Kingdom
Administrative Information
NCT NumberNCT04916470
Other Study ID NumbersEX9536-4773
Has Data Monitoring CommitteeNo
U.S FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes

Studies a U.S. FDA-regulated Device Product: No

Product Manufactured in and Exported from the U.S.: Not Provided

IPD Sharing StatementPlan to Share IPD: Yes
Responsible PartyNovo Nordisk A/S, Novo Nordisk A/S
Study SponsorNovo Nordisk A/S
CollaboratorsNot Provided
Investigators
PRS AccountNovo Nordisk A/S
Verification DateMarch 2024