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Impact of GLP1-RAs on inflammation and endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 trial.
EU CTIS ID: 2025-520802-37-00
What this study is testing
- 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%.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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%.
You likely can't join if
- Age > 85 years.
- 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.
See the full eligibility 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.
- Age > 85 years.
- 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.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.