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Mechanisms of Semaglutide Therapy in Heart Failure Patients
Plain-language guide to NCT06541509: phase 1, phase 2 interventional trial of Semaglutide, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06541509
- Phase
- phase 1, phase 2
- Status
- status unknown
- Start
- 2024-07-10
- Completion (planned or actual)
- 2025-07-10
- Participants
- 10 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Heart Failure; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1, phase 2) is built around Semaglutide.
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.
It had 1 arm (groups): Semaglutide Therapy (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 10 planned participants were the target.
It was open to people of any sex aged from 20 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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.
The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: pregnancy or potential to become pregnant; 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); hospitalization in the past 3 months for reasons other than heart failure.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2024-07-10 with completion listed for 2025-07-10.
It ran at 3 sites in United States (2) and Slovenia (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Interleukin-6 (IL-6) (time frame: 4 months). Interleukin-8 (IL-8) (time frame: 4 months). Tumor Necrosis Factor-alpha (TNF-α) (time frame: 4 months).
It also tracked 9 secondary outcomes, for example Left ventricular end-systolic volume (LVESV), Left ventricular end-diastolic volume (LVEDV), Myocardial mass, Left ventricular ejection fraction (LVEF), Left ventricular filling pressures (E/e') and Global longitudinal strain (GLS).
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Semaglutide in 10 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Semaglutide compound page, all human trials.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.