Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
NCT04788511 · Completed
Last updated 2026-05-28This study is testing how well the medication semaglutide works in people who have both heart failure and obesity.
What this study is testing ClinicalTrials.gov NCT04788511 ↗
Description as written by the study sponsor.
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.
Treatments tested
- Semaglutide Drug
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.
- Placebo (semaglutide) Drug
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.
| Main thing measured | Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) |
|---|---|
| Sponsor | Novo Nordisk A/S |
| Conditions studied | Obesity |
| GLP-1 drugs | semaglutide |
Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT04788511 ↗