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STABLE-GLP1

RecruitingPhase 4

GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM

Impact of GLP1-RAs on Inflammation and Endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 Trial

Lead sponsor

Federico II University

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Type 2 diabetes

Key I/E criterion

•EF ≥50%

Primary endpoints

•Effects of semaglutide in addition to standard therapy on inflammatory•Effects of semaglutide in addition to standard therapy on biomarkers

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 IDNCT07314684

Org study IDP2022TF9AH

Secondary ID2025-520802-37-00

Timeline

Milestones

Study start2025-09-08actual

Study first posted2026-01-02actual

Last update posted2026-01-02actual

Primary completion2027-03-08estimated

Study completion2027-03-08estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years.

•Diagnosis of T2DM in patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10% with clinical indication in accordance with current guidelines [1] to initiate semaglutide therapy (level of evidence IIa).

•Evaluable, pre-randomization CTA with no evidence of stenosis ≥50% of epicardial coronary vessels, as confirmed by the core laboratory, performed within 2 years prior to inclusion.

•Stable clinical conditions, with controlled blood pressure, lipid profile, and glycemic values, based on assessments performed within 4 weeks prior to inclusion.

•Stable antidiabetic treatment for at least 6 weeks.

•Left ventricular ejection fraction ≥50%.

•For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at enrollment by one of the following:

(a) Postmenopausal, defined as amenorrhea for ≥12 months following cessation of fall exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. (b) Documentation of irreversible surgical sterilization by hysterectomy bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.

•Ability to understand study procedures and sign informed consent.

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

•Age > 85 years.

•Previous treatment with semaglutide or GLP1-RAs.

•Patients with stenosis of epicardial coronary arteries ≥50%.

•eGFR <45 mL/min/1.73 m2 irrespective of albuminuria or eGFR 45-59 mL/min/1.73 m2 and microalbuminuria (UACR 30-300 mg/g; stage A2) or proteinuria (UACR >300 mg/g; stage A3) or presence of microvascular disease in at least three different sites [e.g. microalbuminuria (stage A2) plus retinopathy plus neuropathy], based on assessments performed within 4 weeks prior to inclusion.

•History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.

•Any history of ASCVD.

•Ongoing New York Heart Association Class IV (heart failure (HF).

•Significant valvulopathy.

•Type 1 diabetes mellitus.

•Hypersensitivity to the active substance or to any of the excipients.

•Known or suspected liver disease, defined by serum transaminase and alkaline phosphatase levels 3 times the normal level.

•Patients with acute inflammatory or infectious diseases during the 3 months prior to inclusion in the study.

•Patients with chronic inflammatory, immune or infectious diseases.

•Patients with a history of cancer within the past 5 years.

•History of alcohol, drug or medication abuse.

•Patients exposed to any other type of radiation, medical or professional.

•Clinically relevant haematological disorders.

•Decompensated metabolic disorders.

•Abuse of alcohol or drugs in the previous 3 months.

Endpoints (12)

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

Cardiovascular outcomes

Other (unclassified)

Cardiometabolic biomarkers

Safety / tolerability / PK

Cardiovascular outcomes

4 endpoints

Secondary/protocol endpoint/low confidence

To retrospectively evaluate characteristics of subclinical atherosclerotic coronary plaques at CTA in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:At baseline retrospectively

descriptive

Secondary/protocol endpoint/low confidence

To correlate characteristics of subclinical atherosclerotic coronary plaques at CTA in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10% to biomarkers evaluated at baseline.

Time frame:At baseline

descriptive

Secondary/protocol endpoint

To associate FAI at CTA with the incidence of MACE evaluated at 52 weeks in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

Expanded / custom MACE composite

threshold achievement, event

Other/protocol endpoint

To evaluate the effect of semaglutide in addition to standard therapy on time to MACE compared with standard therapy alone in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

Expanded / custom MACE composite

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke, Unstable angina hospitalization, Coronary revascularization

Cardiometabolic biomarkers

2 endpoints

Primary/protocol endpoint

To evaluate the effects of semaglutide in addition to standard therapy on inflammatory biomarkers compared with standard therapy alone in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

change from baseline, improvement

Primary/protocol endpoint

To evaluate the effects of semaglutide in addition to standard therapy on biomarkers of endothelial dysfunction compared with standard therapy alone in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

To assess the safety of semaglutide in addition to standard therapy compared with standard therapy alone in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

Treatment-emergent AEs (any)

threshold achievement, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

To assess the tolerability of semaglutide in addition to standard therapy compared with standard therapy alone in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

Discontinuation due to AE

threshold achievement, event

Other (unclassified)

4 endpoints

Secondary/protocol endpoint/low confidence

To retrospectively evaluate fat attenuation index (FAI) at CTA in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:At baseline retrospectively

descriptive

Secondary/protocol endpoint/low confidence

To correlate FAI in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10% to biomarkers evaluated at baseline.

Time frame:At baseline

descriptive

Secondary/protocol endpoint/low confidence

To correlate FAI at CTA to biomarkers evaluated at 52 weeks in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

descriptive

Secondary/protocol endpoint/low confidence

To correlate characteristics of subclinical atherosclerotic coronary plaques at CTA to biomarkers evaluated at 52 weeks in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%.

Time frame:From enrollment to the end of treatment at 52 weeks

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes.
European heart journal2023 Oct 14PMID37622663doi:10.1093/eurheartj/ehad192via CT.gov background

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.