Effect Of Semaglutide In Coronary Atheroma Plaque
- Status
- UnknownResults none
- Why it is watched
- non-weight indication: cardiovascular
- Who it enrolls
- age 35 Years to 65 Years; excludes diabetes; no BMI minimum stated; conditions: Atheroscleroses, Coronary
- Interventions
- Semaglutide
- Conditions
- Atheroscleroses, Coronary
- Phase and size
- Phase 3 · 120 participants
- Dates
- Start 2021-11
Primary completion 2024-12 - Sponsor
- Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- Plaque burden modification assessed by coronary CT and plaque quantification18 months
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.