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Clinical Trial NCT07314684 (STABLE-GLP1) for T2DM (Type 2 Diabetes Mellitus) is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Federico II UniversityGLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM (STABLE-GLP1) Phase 4 80 Biomarker-Driven Randomized
Clinical Trial NCT07314684 (STABLE-GLP1) is designed to study Treatment for T2DM (Type 2 Diabetes Mellitus). It is a Phase 4 interventional study that is recruiting, having started on September 8, 2025, with plans to enroll 80 participants. Led by Federico II University, it is expected to complete by March 8, 2027. The latest data from ClinicalTrials.gov was last updated on January 2, 2026.
Brief Summary
Type II diabetes mellitus (T2DM) is a chronic disease associated with a very high risk of developing cardiovascular (CV) events, especially because of its long-term effects. Glucagon-like-peptide-1 receptor agonists (GLP1-RAs) are recommended in subjects suffering from T2DM with a history or at risk for CV disease; however there is a lack of evidence on local actions of GLP1-RAs on inflammation and endothelial functi...Show More
Official Title
Impact of GLP1-RAs on Inflammation and Endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 Trial
Conditions
T2DM (Type 2 Diabetes Mellitus)Publications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- STABLE-GLP1
- P2022TF9AH
- 2025-520802-37-00 (EU Study (CTIS) Number)
NCT ID Number
Start Date (Actual)
2025-09-08
Last Update Posted
2026-01-02
Completion Date (Estimated)
2027-03-08
Enrollment (Estimated)
80
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Type 2 Diabetes Mellitus
Semaglutide
Inflammation
Endothelial function
Biomarkers
Coronary Plaque
Semaglutide
Inflammation
Endothelial function
Biomarkers
Coronary Plaque
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalSemaglutide in addition to standard therapy | Semaglutide The starting dose is 0.25 mg semaglutide once weekly. After 4 weeks the dose should be increased to 0.5 mg once weekly. After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control. Standard Treatment (Guideline-Based) Patients will receive standard therapy for T2DM according to standard clinical practice (Guideline-Based). This might include Biguanides, Insulins, Sulfonylureas, SGLT2 inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, or DPP-4 inhibitors. |
ExperimentalStandard therapy alone | Standard Treatment (Guideline-Based) Patients will receive standard therapy for T2DM according to standard clinical practice (Guideline-Based). This might include Biguanides, Insulins, Sulfonylureas, SGLT2 inhibitors, Thiazolidinediones, Alpha-glucosidase inhibitors, or DPP-4 inhibitors. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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%. | Regarding this endpoint, the change in inflammatory biomarkers involved in atherogenesis at follow-up compared to baseline will be evaluated in both treatment arms. Inflammatory biomarkers will be measured in serum using an appropriately validated immunoassay (ELISA - enzyme-linked immunosorbent assay). Inflammatory biomarkers include C-reactive protein (CRP), interleukins (IL-1β, IL-6, IL-10), colony-stimulating factors (M-CSF), tumor necrosis factors (TNF-α), interferons (IFN-γ), transforming growth factors (TGF-β), and adiponectin, all measured in picograms per milliliter (pg/mL). | From enrollment to the end of treatment at 52 weeks |
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%. | Regarding this endpoint, the change in biomarkers involved in endothelial dysfunction at follow-up compared to baseline will be evaluated in both treatment arms. Biomarkers of endothelial dysfunction will be measured in serum using an appropriately validated immunoassay (ELISA - enzyme-linked immunosorbent assay), and include soluble endothelin-1 (ET-1), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1), E-selectin, and P-selectin, all measured in nanograms per milliliter (ng/mL). | From enrollment to the end of treatment at 52 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
To retrospectively evaluate fat attenuation index (FAI) at CTA in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%. | Regarding this endpoint, data from CTA, performed according to clinical practice before enrollment, will be recorded. FAI will be evaluated retrospectively using dedicated software and measured in Hounsfield Units (HU). | At baseline retrospectively |
To retrospectively evaluate characteristics of subclinical atherosclerotic coronary plaques at CTA in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%. | Regarding this endpoint, data from CTA, performed according to clinical practice before enrollment, will be recorded. Coronary plaque size will be evaluated retrospectively using dedicated software and measured as a percentage (%). | At baseline retrospectively |
To correlate FAI in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10% to biomarkers evaluated at baseline. | Data from CTA, performed according to clinical practice before enrollment, will be recorded. This outcome measure evaluates the correlation between FAI (measured in Hounsfield Units) at CTA and circulating biomarkers measured at baseline (ng/mL or pg/mL). Correlation will be assessed using Pearson or Spearman correlation coefficients, as appropriate. | At baseline |
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. | Data from CTA, performed according to clinical practice before enrollment, will be recorded. This outcome measure evaluates the correlation between coronary plaque size (%) at CTA and circulating biomarkers measured at baseline (ng/mL or pg/mL). Correlation will be assessed using Pearson or Spearman correlation coefficients, as appropriate. | At baseline |
To correlate FAI at CTA to biomarkers evaluated at 52 weeks in T2DM patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10%. | Data from CTA, performed according to clinical practice before enrollment, will be recorded. This outcome measure evaluates the correlation between FAI (measured in Hounsfield Units) at CTA and circulating biomarkers measured at 52 weeks (ng/mL or pg/mL). Correlation will be assessed using Pearson or Spearman correlation coefficients, as appropriate. | From enrollment to the end of treatment at 52 weeks |
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%. | Data from CTA, performed according to clinical practice before enrollment, will be recorded. This outcome measure evaluates the correlation between coronary plaque sizes (%) at CTA and circulating biomarkers measured at 52 weeks (ng/mL or pg/mL). Correlation will be assessed using Pearson or Spearman correlation coefficients, as appropriate. | From enrollment to the end of treatment at 52 weeks |
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%. | Data from CTA, performed according to clinical practice before enrollment, will be recorded. This outcome measure evaluates the association between FAI (measured in Hounsfield Units) at CTA and the occurrence of major adverse cardiovascular events (MACE) during the follow-up period. MACE will be analyzed as a binary outcome (presence/absence) and reported as incidence (% of patients with at least one event). The association between baseline FAI and MACE will be assessed using logistic regression and/or Cox proportional hazards models (time-to-first event), as appropriate. | From enrollment to the end of treatment at 52 weeks |
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%. | Concerning this endpoint, safety will be measured as the percentage (%) of patients reporting adverse events and/or serious adverse events, and analyzed in both treatment arms.
An adverse event is any untoward medical occurrence in a patient or clinical study participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse events can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product, whether or not considered drug related.
A Serious Adverse Event or reaction is any untoward medical occurrence that, at any dose, results in death, is lifethreatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect. | From enrollment to the end of treatment at 52 weeks |
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%. | Concerning this endpoint, tolerability will be assessed primarily through treatment discontinuation rates and analyzed in both treatment arms. Discontinuation rates will be measured as the percentage (%) of patients discontinuing treatment. | From enrollment to the end of treatment at 52 weeks |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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.
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.
Federico II University91 active studies to exploreStudy Responsible Party
Pasquale Perrone Filardi, Principal Investigator, Professor, Federico II University
No contact data.
2 Study Locations in 1 Countries
Caserta
Azienda Ospedaliera Sant'Anna e San Sebastiano, Caserta, Caserta, 81100, Italy
Felice Gragnano, Contact, 00000, [email protected]
Recruiting
Napoli
Federico II University, Naples, Napoli, 80131, Italy
Pasquale Perrone Filardi, Contact, 0817462224, [email protected]
Recruiting