Phase 3
N=529
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT04788511 ↗Enrolled (actual)
529
Serious AEs
20.0%
Results posted
Jun 2024
Primary outcome: Primary: Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) — 16.8; 10.3 Score on a scale — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Semaglutide (Drug); Placebo (semaglutide) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) |
16.8; 10.3 | <0.0001 sig |
| PRIMARY Change in Body Weight |
-13.9; -2.5 | <0.0001 sig |
| SECONDARY Change in Six-minute Walking Distance (6MWD) |
23.5; 5.8 | — |
| SECONDARY The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs |
60.1; 34.9 | — |
| SECONDARY Change in C-Reactive Protein (CRP): Ratio to Baseline |
0.55; 0.92 | — |
| SECONDARY Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No) |
34.1; 90.5; 65.9; 9.5 | — |
| SECONDARY Percentage of Participants Achieving 15% Weight Loss (Yes/No) |
56.1; 97.9; 43.9; 2.1 | — |
| SECONDARY Percentage of Participants Achieving 20% Weight Loss (Yes/No) |
76.4; 99.6; 23.6; 0.4 | — |
| SECONDARY Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No) |
24.7; 36.3; 75.3; 63.7 | — |
| SECONDARY Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No) |
36.6; 51.5; 63.4; 48.5 | — |
| SECONDARY Change in KCCQ Overall Summary Score (KCCQ-OSS) |
16.8; 10.9 | — |
| SECONDARY Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S) |
43.2; 32.5 | — |
| SECONDARY Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S) |
42.5; 28.0 | — |
| SECONDARY Change in Systolic Blood Pressure (SBP) |
-6.4; -1.1 | — |
| SECONDARY Change in Waist Circumference |
-12.0; -2.8 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT04788511). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.