Semaglutide in Patients Undergoing Transcatether Aortic Valve Replacement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

826 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-01

Study Completion Date

2031-04-01

Brief Summary

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This is a Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial evaluating the safety and efficacy of once-weekly semaglutide 2.4 mg in adult patients undergoing transcatheter aortic valve replacement (TAVR) for severe aortic stenosis (AS) who meet current clinical criteria for semaglutide treatment. A total of 826 participants will be randomized 1:1 to receive semaglutide or placebo as an add-on to standard-of-care, starting 3 months before TAVR and continuing for 24 months post-procedure. The primary endpoint is time to first occurrence of a composite of cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke or transient ischemic accident (TIA), and hospitalization for heart failure (HF). The study is event-driven and powered to detect a 20% relative risk reduction in primary outcome events. This trial aims to address the unmet need for medical therapies that improve outcomes in patients with severe AS following TAVR, with potential for direct clinical implementation.

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Detailed Description

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Conditions

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Aortic Stenosis Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a Phase III, randomized, placebo-controlled, double-blinded, multi-center clinical trial conducted at five centers in the Netherlands, comparing semaglutide 2.4 mg with placebo both administered subcutaneous (sc) once-weekly in subjects with severe AS undergoing TAVR with obesity or overweight and CV risk factors. Eligible subjects will be randomized in a 1:1 manner to receive either semaglutide sc. 2.4 mg or placebo once-weekly as an add-on to standard-of-care.

Interventions:

* Treatment Arm: Semaglutide 2.4 mg subcutaneous once-weekly starting 3 months prior TAVR and continued 24 months post-TAVR. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose as an add-on to standard-of-care. The treatment will continue until the 'end of treatment' visit followed by a 8 weeks follow-up period.
* Control Arm: Matching placebo subcutaneous once-weekly.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

This is a double-blind study. Participants, care providers, investigators, and outcome assessors will be blinded to treatment allocation. Semaglutide and placebo will be identical in appearance and administered in the same manner.

Study Groups

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Treatment Arm

Group Type ACTIVE_COMPARATOR

Wegovy ®

Intervention Type DRUG

Semaglutide 2.4 mg subcutaneous once-weekly starting 3 months prior TAVR and continued 24 months post-TAVR. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose as an add-on to standard-of-care. The treatment will continue until the 'end of treatment' visit followed by a 8 weeks follow-up period.

Control Arm

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo subcutaneous once-weekly.

Interventions

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Wegovy ®

Semaglutide 2.4 mg subcutaneous once-weekly starting 3 months prior TAVR and continued 24 months post-TAVR. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose as an add-on to standard-of-care. The treatment will continue until the 'end of treatment' visit followed by a 8 weeks follow-up period.

Intervention Type DRUG

Placebo

Matching placebo subcutaneous once-weekly.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No