NCT06423599RecruitingPhase 2/3
Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
Source: ClinicalTrials.gov · Last updated 23 Jun 2026
Brief summary (registry, in English)
The benefit of weight loss in patients with obesity and heart failure with reduced ejection fraction (HFrEF) is controversial. Semaglutide has shown cardiovascular (CV) risk-reduction and impact on CV risk factors including overweight, dysglycaemia and hypertension in subjects with type 2 diabetes (T2D). The STEP-HFpEF (Semaglutide Treatment Effect in People With Obesity and HFpEF) recently demonstrated, at 1-year, to not only reduce weight considerably, but also significantly improve health-related quality of life, functional status scores and 6-min walk distance in patients with heart failure with preserved ejection fraction (HFpEF). Also, the recently concluded SELECT trial was the first CV outcome trial with semaglutide in patients with overweight or obesity and established CV disease, including heart failure (but no T2D). Semaglutide demonstrated a 20% reduction in MACE, defined as the composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. These landmark findings have important implications for clinicians -as they mean that weight loss and/or semaglutide as anti-obesity pharmacotherapy could be a treatment strategy for secondary prevention of CV disease in patients with overweight or obesity. It is, however, unknown whether weight loss with either calorie-restricted diet or semaglutide has beneficial effects in obese subjects with heart failure and reduced ejection fraction. Also it is unclear whether semaglutide has cardiovascular benefits irrespective of starting weight and amount of weight loss. Purpose: The study aims to investigate whether weight loss treatment with semaglutide is superior to weight loss with calorie-restricted diet in improving peak oxygen uptake in patients with obesity and heart failure with reduced ejection fraction.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 16 May 2024
- Start date
- 30 Apr 2024
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- Jens D Hove, MD,PHD
- Diseases
- Heart failure, Obesity
- NCT number
- NCT06423599
- EU CT number
- 2023-503753-35-01
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 100
- From 30 Apr 2024 to the primary completion date, 30 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiovascular-related:
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 6 months prior to the day of screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc.
Lab values
- Glycaemia-related:
- Type 1 diabetes
- Treatment with any Glucagon-Like Peptide-1 (GLP-1) agonists within 90 days prior to the day of screening
- Type 2 diabetes requiring other pharmacotherapy than metformin and Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors
- General safety:
- Pregnancy or planned pregnancy
- History or presence of chronic pancreatitis
- Presence of acute pancreatitis within the past 180 days prior to the day of screening
- Kidney disease with eGFR \< 35ml/min
- Presence or history of malignant neoplasms within the past 5 years prior to the day of screening (Basal and squamous cell skin cancer and any carcinoma in-situ are allowed)
- Known or suspected hypersensitivity to trial product(s) or related products
Who the study is looking for
- Male or female, age ≥ 18 years at the time of signing informed consent
- Body mass index (BMI) ≥ 30 kg/m2
- Heart failure with New York Heart Association (NYHA)-class 1-3 and reduced ejection fraction (EF≤40%) established by either:
- echocardiography AND/OR
- cardiac magnetic resonance
- On stable optimal medical heart failure therapy for at least 4 weeks
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hvidovre Hospital Coordinator of this site? Confirm its status | Hvidovre | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.