NCT06541509 Mechanisms of Semaglutide Therapy in Heart Failure Patients
| NCT ID | NCT06541509 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-07-10 |
| Primary Completion | 2025-07-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2024-07-10 with a primary completion date of 2025-07-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. In addition, GLP-1 receptor agonists appear to have multiple extrapancreatic actions, which remain poorly defined. In large clinical trials, semaglutide improved the outcomes in obese patients, patients with heart failure with preserved ejection fraction, and decreased the heart failure hospitalizations in patients with type 2 diabetes. The aim of the present study is to investigate the underlying mechanisms of the beneficial clinical effects of semaglutide in the setting of chronic heart failure.
Eligibility Criteria
Inclusion Criteria: * Age: 20-80 years * Presence of heart failure * Body-mass index 27 kg/m2 or greater * Stable optimally tolerated dosages of heart failure therapies for 3 months * N-terminal pro B-type natriuretic peptide levels \>350 pg/mL Exclusion Criteria: * Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5% * Pregnancy or potential to become pregnant * Cancer * Liver dysfunction (aspartate aminotransferase and/or alanine aminotransferase \> 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal) * Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2) * Hospitalization in the past 3 months for reasons other than heart failure * New York Heart Association (NYHA) functional class I or functional class IV symptoms. * Prior or planned bariatric surgery * Self-reported change in body weight \>11 lbs (5 kg) within 3 months before enrollment * Acute or chronic infection
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06541509 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 80 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06541509 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06541509 currently recruiting?
Yes, NCT06541509 is actively recruiting participants. Contact the research team at bojan.vrtovec@kclj.si for enrollment information.
Where is the NCT06541509 trial being conducted?
This trial is being conducted at Palo Alto, United States, Stanford, United States, Ljubljana, Slovenia.
Who is sponsoring the NCT06541509 clinical trial?
NCT06541509 is sponsored by University Medical Centre Ljubljana. The trial plans to enroll 10 participants.
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