Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
Completed · Phase 3 · Has a placebo group
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT04788511
- Run by
- Novo Nordisk A/S
- People needed
- 529
- Starts
- 2021-03-16
- Expected to finish
- 2023-04-18
- Last updated by the study team
- 2025-12-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- National Heart Institute Cal — Beverly Hills, California, United States
- Keck Medical Center of USC - Outpatient Clinic — Los Angeles, California, United States
- Lundquist Inst-Biomed Innovtn — Torrance, California, United States
- Jacksonville Ctr For Clin Res — Jacksonville, Florida, United States
- First Coast Cardiovascular Institute — Jacksonville, Florida, United States
- Baptist Heart Specialists_Jacksonville — Jacksonville, Florida, United States
- CV Res Ctr of S Florida — Miami, Florida, United States
- Endeavor Health Clinical Operations-NCH — Arlington Heights, Illinois, United States
- University of Chicago Medicine — Chicago, Illinois, United States
- Endeavor Health Glenbook Hosp — Evanston, Illinois, United States
- Northwestern University_Chicago_0 — Evanston, Illinois, United States
- Chicago Medical Research LLC — Hazel Crest, Illinois, United States
- Ascension St. Vincent Medical Group — Indianapolis, Indiana, United States
- University of Iowa — Iowa City, Iowa, United States
- University of Kansas Medical Center_Kansas City — Kansas City, Kansas, United States
- Cotton-O'Neil Heart Center — Topeka, Kansas, United States
- The Research Group of Lexington LLC — Lexington, Kentucky, United States
- Baptist Health Louisville — Louisville, Kentucky, United States
- Baptist Health Madisonville, Inc — Madisonville, Kentucky, United States
- Grace Research, LLC — Bossier City, Louisiana, United States
- Heart Clinic of Hammond — Hammond, Louisiana, United States
- Grace Research, LLC_Shreveport — Shreveport, Louisiana, United States
- Louisiana Heart Center_Slidell — Slidell, Louisiana, United States
- Louisiana Heart Center — Slidell, Louisiana, United States
- Eastern Shore Rsrch Inst, LLC — Fairhope, Alabama, United States
Full record on ClinicalTrials.gov
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