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SEMAHEART

RecruitingPhase 1, PHASE2

Mechanisms of Semaglutide Therapy in Heart Failure Patients

A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients

Lead sponsor

University Medical Centre Ljubljana

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Heart failure, Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Interleukin-6 (IL-6)•Interleukin-8 (IL-8)•Tumor Necrosis Factor-alpha (TNF-α)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06541509

Org study IDSEMAHEART

Timeline

Milestones

Study start2024-07-10actual

Study first posted2024-08-07actual

Last update posted2024-08-07actual

Primary completion2025-07-10estimated

Study completion2025-09-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age20 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Heart failure

Weight & body composition

Safety / tolerability / PK

Glycemic / diabetes

MASH / liver

Cardiometabolic biomarkers

Weight & body composition

3 endpoints

Primary/protocol endpoint

Body mass index

Time frame:4 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Lean body mass

Time frame:4 months

Lean mass

descriptive

Secondary/protocol endpoint

Fat mass

Time frame:4 months

Total fat mass

descriptive

Glycemic / diabetes

1 endpoint

Primary/protocol endpoint

Hemoglobin A1C (HgA1C)

Time frame:4 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

1 endpoint

Primary/protocol endpoint/low confidence

Liver Function Tests (LFT)

Time frame:4 months

descriptive

Heart failure

5 endpoints

Primary/protocol endpoint

B-type Natriuretic Peptide (BNP)

Time frame:4 months

NT-proBNP, change

concentration, descriptive

Secondary/protocol endpoint/low confidence

Left ventricular end-systolic volume (LVESV)

Time frame:4 months

descriptive

Secondary/protocol endpoint/low confidence

Left ventricular end-diastolic volume (LVEDV)

Time frame:4 months

descriptive

Secondary/protocol endpoint

Left ventricular ejection fraction (LVEF)

Time frame:4 months

descriptive

Secondary/protocol endpoint

Exercise capacity

Time frame:4 months

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Primary/protocol endpoint

C-reactive Protein (CRP)

Time frame:4 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Complete Blood Count (CBC)

Time frame:4 months

descriptive

Primary/protocol endpoint/low confidence

Comprehensive Metabolic Panel (Chem 7)

Time frame:4 months

descriptive

Other (unclassified)

7 endpoints

Primary/protocol endpoint/low confidence

Interleukin-6 (IL-6)

Time frame:4 months

concentration, descriptive

Primary/protocol endpoint/low confidence

Interleukin-8 (IL-8)

Time frame:4 months

concentration, descriptive

Primary/protocol endpoint/low confidence

Tumor Necrosis Factor-alpha (TNF-α)

Time frame:4 months

concentration, descriptive

Primary/protocol endpoint/low confidence

Interferon-gamma (IFN-γ)

Time frame:4 months

concentration, descriptive

Secondary/protocol endpoint/low confidence

Myocardial mass

Time frame:4 months

descriptive

Secondary/protocol endpoint/low confidence

Left ventricular filling pressures (E/e')

Time frame:4 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Global longitudinal strain (GLS)

Time frame:4 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.