Effect Of Semaglutide In Coronary Atheroma Plaque (NCT05071417) | Clinical Trial Compass
UnknownPhase 3
Effect Of Semaglutide In Coronary Atheroma Plaque
120 participantsStarted 2021-11
Plain-language summary
The main objective of this trial is to evaluate the effect of Semaglutide on the burden of coronary atherosclerosis, based on the change in Percent Atheroma Volume (PAV) by quantifying atheroma plaque throughout the coronary tree based on the analysis of CCTA in asymptomatic subjects with T2D in optimized and stable treatment with Semaglutide.
Who can participate
Age range
35 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men and women ≥35 and ≤ 65 years
* Absence of previous history of clinical cardiovascular events
* Subjects already taking therapy for diabetes on stable doses for 3 months or more.
* Subjects must have HbA1c at the initial screening visit between 8 and 10%
* Coronary CT performed less than 3 months before starting study medication
Exclusion Criteria:
* Clinically significant heart disease
* New York Heart Association (NYHA) class \>II
* Known stroke or transient ischemic accident
* Uncontrolled hypertension at randomization, defined as a resting systolic blood pressure of 180 mm Hg at rest
* Personal or family history of hereditary muscular disorders
* Fasting triglyceride level \> 250 mg/dL at screening
* Type 1 diabetes
* Known thyroid disease or subject taking thyroid replacement therapy
* Estimated glomerular filtration rate \< 60 ml/min/1.73m2
* History of malignancy
* Known major active infection, or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
* Baseline coronary CT does not meet Core Lab technical standards
* Cardiac rhythm different to normal sinus rhythm.
* Female subjects cannot be pregnant or breastfeeding, planning to become pregnant or planning to breastfeed during the entire study
* Premenopausal females of childbearing potential must be willing to use an acceptable method(s) of birth control during treatment and for an additional 15 weeks after the end of treatment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plaque burden modification assessed by coronary CT and plaque quantification
Timeframe: 18 months
Trial details
NCT IDNCT05071417
SponsorFundación Instituto de Estudios de Ciencias de la Salud de Castilla y León