Effect Of Semaglutide In Coronary Atheroma Plaque

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León

Criteria

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