Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

Inclusion criteria

Subjects are eligible to be included in the trial only if all of the following criteria apply:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
• Adults (≥18 years) undergoing TAVR for severe AS, and
• BMI ≥30 kg/m2, or
• BMI 27-30 kg/m2, AND at least one of the following:
• Dysglycemia (prediabetes or type 2 diabetes) ≥90 days prior to the day of screening with HbA1c of ≤ 10.0% as measured at the screening visit.
• Arterial Hypertension
• Hypercholesterolemia
• Obstructive sleep apnea
• History of stroke (ischemic or hemorrhagic)
• History of myocardial infarction
• Symptomatic peripheral artery disease (intermittent claudication with ankle-brachial index <0.85, peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease)

Exclusion criteria

• Treatment with an GLP-1 receptor agonist within the previous 90 days.
• Myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the previous 60 days.
• Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
• eGFR <25 mL/min/1.73 m² or intermittent hemodialysis or peritoneal dialysis.
• Presence of acute pancreatitis within the last 180 days prior to screening.
• History or presence of chronic pancreatitis.
• Self-reported change in body weight of >5 kg within 90 days before screening.
• Bariatric surgery prior to screening or planned bariatric surgery within the trial time course.
• Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.
• Known or suspected hypersensitivity to trial product(s) or related products.
• Participation in any clinical trial of an approved or non-approved device for the treatment of aortic stenosis or obesity within 30 days before screening.
• Receipt of any investigational medicinal product within 30 days before screening.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
• Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.
• Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.