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New treatment option for Heart Failure With Reduced Ejection Fraction
Official title Effect of Weight Loss on Physical and Cardiac Performance in People With Obesity and Heart Failure
ClinicalTrials.gov ID: NCT06423599
What this study is testing
What is Semaglutide Injectable Product?
Semaglutide Injectable Product is an investigational medicine, given as an once-weekly, being studied as a potential treatment for heart failure with reduced ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Cardiovascular-related:
- Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 6...
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
- Transient heart failure related to reversible mechanisms like tachycardia, sepsis, etc.
- Glycaemia-related:
- Type 1 diabetes
See the full eligibility criteria
- 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
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Copenhagen, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Copenhagen, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.