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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
EU CTIS ID: 2025-522486-29-01
What this study is testing
Cohort 1: To explore the effects of different doses of oral semaglutide versus control on platelet reactivity in type 2 diabetic patients with an indication to GLP-1 RA undergoing aspirin or aspirin + clopidogrel. Cohort 2: To explore the effects of different doses of subcutaneous semaglutide versus control on platelet reactivity in obese (BMI≥30 kg/m2) or overweight (BMI≥27 kg/m2) non-diabetic patients with at least one weight-related comorbidity or established CV disease, undergoing aspirin or aspirin + clopidogrel.
- Therapeutic confirmatory (Phase III)
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
- Cohort 1: Type 2 Diabetes mellitus AND an indication for GLP-1 RA treatment as per the ESC guidelines. Cohort 2: BMI≥30kg/m2 OR BMI≥27 kg/m2 non-diabetic patients AND an indication for GLP-1 RA treatment as per the ESC guidelines, including patients with the presence of at least one weight-related comorbidities (hypertension, dyslipidemia, obstructive sleep apnea), OR established CV disease, defined as prior MI, stroke (ischemic and hemorrhagic stroke), or symptomatic PAD (as evidenced by intermittent claudication with ankle–brachial index <0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease).
- On treatment with aspirin (81-100 mg/od) alone or aspirin (81-100 mg/od) plus clopidogrel (75mg/od) as per standard of care since at least 14 days before enrolment;
- Male or female aged >45 and <75 years;
- Are willing to be consented and to understand the study requirements, to adhere to study treatments, and complete all assessments and all scheduled visits, per Investigator judgment.
- All women of childbearing potential must agree to use highly effective contraception from the time of informed consent until at least 8 weeks after the last dose of the investigational medicinal product.
- Blood tests not older than 2 months including hemoglobin (Hb), estimated glomerular filtration rate (eGFR), aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
You likely can't join if
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris, transient ischemic attack or other arterial or venous thrombosis within the past 90 days prior to the day of screening
- History or presence of acute or chronic pancreatitis
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- Proliferative retinopathy or maculopathy requiring acute treatment
- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
See the full eligibility criteria
- Cohort 1: Type 2 Diabetes mellitus AND an indication for GLP-1 RA treatment as per the ESC guidelines. Cohort 2: BMI≥30kg/m2 OR BMI≥27 kg/m2 non-diabetic patients AND an indication for GLP-1 RA treatment as per the ESC guidelines, including patients with the presence of at least one weight-related comorbidities (hypertension, dyslipidemia, obstructive sleep apnea), OR established CV disease, defined as prior MI, stroke (ischemic and hemorrhagic stroke), or symptomatic PAD (as evidenced by intermittent claudication with ankle–brachial index <0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease).
- On treatment with aspirin (81-100 mg/od) alone or aspirin (81-100 mg/od) plus clopidogrel (75mg/od) as per standard of care since at least 14 days before enrolment;
- Male or female aged >45 and <75 years;
- Are willing to be consented and to understand the study requirements, to adhere to study treatments, and complete all assessments and all scheduled visits, per Investigator judgment.
- All women of childbearing potential must agree to use highly effective contraception from the time of informed consent until at least 8 weeks after the last dose of the investigational medicinal product.
- Blood tests not older than 2 months including hemoglobin (Hb), estimated glomerular filtration rate (eGFR), aspartate aminotransferase (AST) and alanine aminotransferase (ALT).
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris, transient ischemic attack or other arterial or venous thrombosis within the past 90 days prior to the day of screening
- History or presence of acute or chronic pancreatitis
- History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
- Proliferative retinopathy or maculopathy requiring acute treatment
- Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years
- Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
- Currently enrolled in a competing randomized trial or less than 30 days since ending another trial with an investigational product or device
- Presence of medical conditions that would make the patient unlikely to compliant with study related procedures
- Women who are pregnant, breast feeding or may be considering pregnancy during the study period
- On treatment with anticoagulant agents or with antiplatelets other than aspirin or aspirin and clopidogrel
- Use of any DPP-4 inhibitor, any GLP-1 RA or pramlintide within 30 days prior to screening
- Known or suspected hypersensitivity to semaglutide or related products;
- Concomitant or expected chronic use of steroids or non-steroidal anti-inflammatory drugs;
- Patient has a diagnosis of type 1 DM, or a history of ketoacidosis
- Presence of severe heart failure – systolic or diastolic NYHA Class 4;
- Presence of end stage renal impairment defined as eGFR <15ml/min, chronic or intermittent hemodialysis or peritoneal dialysis
- Known severe liver disease
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, 65+ years, 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.