Recruiting Phase 3 2025-522486-29-01

Impact of Oral Semaglutide on Platelet Reactivity in Patients with Diabetes Mellitus or Overweight with High Risk or established Cardiovascular Disease: the SEMA-PLAT Study

Phase 3 – large-scale trial before approval

Conditions: Diabetes Mellitus Cardiovascular disease Overweight (BMI ≥27 kg/m²) Obesity (BMI≥30kg/m2)

Sponsor: Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali

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Overview

Trial status: Authorised Changes between groups at different time points (T1, T2 and T3) in: • Markers of thrombus formation (T-TAS AUC, P-selectin, aGPIIbIIIa, PDMP) • Inflammatory markers (IL-1, IL-6); • Oxidative stress markers (H₂O₂, sNOX2-dp, HBA); • Endothelial function markers (NO, endothelin-1); • Autophagy markers (p62, LC3, ATG5). Change in platelet reactivity assessed by light transmission aggregometry [LTA] following ADP (2 and 5 μmol/L) and collagen (2 μg/mL) stimuli between groups at T3;

Description

Changes between groups at different time points (T1, T2 and T3) in: • Markers of thrombus formation (T-TAS AUC, P-selectin, aGPIIbIIIa, PDMP) • Inflammatory markers (IL-1, IL-6); • Oxidative stress markers (H₂O₂, sNOX2-dp, HBA); • Endothelial function markers (NO, endothelin-1); • Autophagy markers (p62, LC3, ATG5).

Who can participate

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 212 participants

Interventions

Wegovy 2.4 mg solution for injection in pre-filled pen

Drug

Rybelsus 14 mg tablets

Drug

Clopidogrel Medreg 75 mg filmom obalené tablety

Drug

Wegovy 0.25 mg solution for injection in pre-filled pen

Drug

Wegovy 0.5 mg solution for injection in pre-filled pen

Drug

Wegovy 1 mg solution for injection in pre-filled pen

Drug

Rybelsus 7 mg tablets

Drug

Wegovy 1.7 mg solution for injection in pre-filled pen

Drug

Acetylsalicylic acid Krka 100 mg enterotabletter

Drug

Rybelsus 3 mg tablets

Drug

Locations 1

Italy (1)

Status

Recruiting

Phase

Phase 3

Study type

INTERVENTIONAL

Sex

Male and female

Minimum age

18 Years

Healthy volunteers

Start date

23.04.2026

Registry ID

2025-522486-29-01

Source

euclinicaltrials.eu

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