T2DM (Type 2 Diabetes Mellitus)Phase 4STABLE-GLP1NCT07314684
GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM
A Phase 4 study testing semaglutide and Standard Treatment (Guideline-Based) in people with T2DM (Type 2 Diabetes Mellitus), run by Federico II University at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- T2DM (Type 2 Diabetes Mellitus)
- What is being tested?
- semaglutide and Standard Treatment (Guideline-Based)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesItaly
- Study dates
- 8 Sep 2025to 8 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- 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:
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera Sant'Anna e San Sebastiano
Caserta, Caserta, 81100
Felice Gragnano, 00000, FELICE.GRAGNANO@unicampania.it
- Recruiting
Federico II University
Naples, Napoli, 80131
Pasquale Perrone Filardi, 0817462224, fpperron@unina.it
About this study
Official title: Impact of GLP1-RAs on Inflammation and Endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 Trial
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 function.
The STABLE-GLP1 study aims to evaluate, in patients with T2DM without atherosclerotic cardiovascular disease (ASCVD) or severe target-organ damage (TOD), the possible beneficial effect of semaglutide, a GLP1-AR, on clinical prognosis, inflammatory and endothelial biomarkers.
The STABLE-GLP1 trial is a phase IV interventional, national, multicenter, randomized, pragmatic study, aiming at enrolling 80 patients with T2DM and no ASCVD. Participants will be randomized in 1:1 ratio to receive semaglutide in addition to standard therapy or standard therapy alone, according to body mass index (BMI) category (BMI <30 vs. ≥30 kg/m²). All patients will perform clinical visit, ECG, echocardiography, blood sample collection for endothelial and inflammatory biomarkers dosage at baseline, at 26 weeks, and after 52 weeks of treatment. Data from CTA, performed according to clinical practice before enrollment, will be recorded and retrospectively evaluated to test secondary outcomes.
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Being tested
- semaglutide, Standard Treatment (Guideline-Based)
- Keywords
- Type 2 Diabetes Mellitus, Semaglutide, Inflammation, Endothelial function, Biomarkers, Coronary Plaque
- Medical subject headings
- Diabetes Mellitus, Type 2, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
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)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide in addition to standard therapy | Experimental | Not described Receives: Drug: semaglutide; Drug: Standard Treatment (Guideline-Based) |
| Standard therapy alone | Experimental | Not described Receives: Drug: Standard Treatment (Guideline-Based) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From enrollment to the end of treatment at 52 weeks
Secondary outcomes (9)
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).
Measured: 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 (%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start8 Sep 2025
- Primary completion8 Mar 2027 (estimated)
- Study completion8 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for T2DM (Type 2 Diabetes Mellitus)Studies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV low-interventional, Italian, multicenter, randomized, pragmatic clinical trial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pasquale Perrone Filardi, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07314684
- Sponsor's protocol ID
- P2022TF9AH
- Other IDs
- 2025-520802-37-00, 2025
- Acronym
- STABLE-GLP1
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marx N, Federici M, Schutt K, Muller-Wieland D, Ajjan RA, Antunes MJ, Christodorescu RM, Crawford C, Di Angelantonio E, Eliasson B, Espinola-Klein C, Fauchier L, Halle M, Herrington WG, Kautzky-Willer A, Lambrinou E, Lesiak M, Lettino M, McGuire DK, Mullens W, Rocca B, Sattar N; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J. 2023 Oct 14;44(39):4043-4140. doi: 10.1093/eurheartj/ehad192. No abstract available.
PubMed 37622663
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of GLP1-RAs on Inflammation and Endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 Trial
- ClinicalTrials.gov ID
- NCT07314684
- Acronym / sponsor ID
- STABLE-GLP1 / P2022TF9AH
- Conditions
- T2DM (Type 2 Diabetes Mellitus)
- Keywords
- Type 2 Diabetes Mellitus, Semaglutide, Inflammation, Endothelial function, Biomarkers, Coronary Plaque
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 Mar 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 function.
The STABLE-GLP1 study aims to evaluate, in patients with T2DM without atherosclerotic cardiovascular disease (ASCVD) or severe target-organ damage (TOD), the possible beneficial effect of semaglutide, a GLP1-AR, on clinical prognosis, inflammatory and endothelial biomarkers.
The STABLE-GLP1 trial is a phase IV interventional, national, multicenter, randomized, pragmatic study, aiming at enrolling 80 patients with T2DM and no ASCVD. Participants will be randomized in 1:1 ratio to receive semaglutide in addition to standard therapy or standard therapy alone, according to body mass index (BMI) category (BMI <30 vs. ≥30 kg/m²). All patients will perform clinical visit, ECG, echocardiography, blood sample collection for endothelial and inflammatory biomarkers dosage at baseline, at 26 weeks, and after 52 weeks of treatment. Data from CTA, performed according to clinical practice before enrollment, will be recorded and retrospectively evaluated to test secondary outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase IV low-interventional, Italian, multicenter, randomized, pragmatic clinical trial
| Arm | Type | Receives |
|---|---|---|
| Semaglutide in addition to standard therapy | Experimental | Drug: semaglutide, Drug: Standard Treatment (Guideline-Based) |
| Standard therapy alone | Experimental | Drug: Standard Treatment (Guideline-Based) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutideThe 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. | Drug | Semaglutide in addition to standard therapy |
| 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. | Drug | Semaglutide in addition to standard therapy, Standard therapy alone |
Primary outcome
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
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).
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
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).
9 secondary outcomes
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
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
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
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
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
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 37622663Marx N, Federici M, Schutt K, Muller-Wieland D, Ajjan RA, Antunes MJ, Christodorescu RM, Crawford C, Di Angelantonio E, Eliasson B, Espinola-Klein C, Fauchier L, Halle M, Herrington WG, Kautzky-Willer A, Lambrinou E, Lesiak M, Lettino M, McGuire DK, Mullens W, Rocca B, Sattar N; ESC Scientific Document Group. 2023 ESC Guidelines for the management of cardiovascular disease in patients with diabetes. Eur Heart J. 2023 Oct 14;44(39):4043-4140. doi: 10.1093/eurheartj/ehad192. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing semaglutide and Standard Treatment (Guideline-Based) in people with T2DM (Type 2 Diabetes Mellitus), run by Federico II University at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07314684, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.