Semaglutide for Non-ST-elevation myocardial infarction (NSTEMI)|Unstable angina|Diabetes mellitus

Inclusion criteria

• {"criterion_text":"- Diagnosis of T2DM\n- Non-ST-segment elevation ACS\n- Presence of one identifiable culprit coronary lesion treated with percutaneous coronary intervention (PCI)\n- Presence of at least one non-culprit, mild to intermediate stenosis (30% to 69% lumen narrowing) at coronary angiography, with a macrophage arc detectable on optical coherence tomography (OCT), on a major epicardial coronary artery different from the culprit vessel\n- Age ≥40 years\n- Signed informed consent."}

Exclusion criteria

• {"criterion_text":"-\tAcute heart failure\n-\tRenal dysfunction (estimated GFR <30 mL/min/1.73 m²) or dialysis\n-\tHistory or high risk of pancreatitis.\n-\tSevere gastroparesis requiring therapy <6 months prior to randomization.\n-\tActive malignancy or history of neuroendocrine tumors.\n-\tHypersensitivity or contraindications to semaglutide or its excipients.\n-\tSevere hepatic dysfunction (ALT/AST >2× upper limit of normal or total bilirubin >1.5× upper limit of normal).\n-\tPregnancy or breastfeeding. Women of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception during the study.\n-\tPatients with diabetic ketoacidosis\n-\tUse of semaglutide at screening within 30 days prior to randomization.\n-\tInability to provide informed consent."}

Primary endpoints

• {"endpoint_text":"- the change of the maximum macrophage arc (degrees) in non-culprit coronary stenoses from baseline to 24 weeks, measured by OCT, in the semaglutide vs control arm","definition_or_measurement_approach":"Measured by optical coherence tomography (OCT): change in maximum macrophage arc in degrees from baseline to 24 weeks comparing semaglutide versus control arm."}

Secondary endpoints

• {"endpoint_text":"- changes from baseline to 24 weeks in OCT parameters (lumen area, plaque volume, fibrous cap thickness, lipid/calcium arcs and lengths), plaque composition (fibrous, fibro-calcific, fibro-atheroma, TCFA), prevalence of healed and macrophage-rich plaques, HbA1c, BMI, and incidence of cardiovascular events and adverse effects.","definition_or_measurement_approach":"Changes from baseline to 24 weeks measured by OCT for imaging parameters; laboratory measures for HbA1c and BMI; clinical follow-up for incidence of cardiovascular events and adverse effects."}

Italy

Earliest CTIS Part Ii Submission Date

20-01-2026

Latest Decision Or Authorization Date

28-01-2026

Processing Time Days

8

Number Of Sites

6

Number Of Participants

90

Primary sponsor

Full Name

Azienda Ospedaliero-Universitaria Maggiore Della Carita

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy