ClinicalTrials.gg
Not yet recruitingNCT05071417SEPLAUpdated Oct 8, 2021

Effect Of Semaglutide In Coronary Atheroma Plaque

A Phase 3 interventional study of Semaglutide in Atheroscleroses, Coronary, sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León. Not yet recruiting. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-10-08.

Sponsored by Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 3
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
35 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Patients with type 2 diabetes mellitus (DM2) are considered to be at high vascular risk (VR). However, the VR risk may vary, depending on the presence of other cardiovascular risk factors (CVRFs), particularly dyslipidemia, smoking habit, hypertension, and obesity. High blood glucose levels are part of the etiopathogenic basis of atherosclerosis, whose vascular complications are the leading cause of death and disability in developed countries. Atherosclerosis is considered a chronic immunoinflammatory process with a polygenic and multifactorial origin that begins early due to vascular endothelial dysfunction. Atherosclerosis is a dynamic process that develops intermittently over time; periods of inactivity and rapid evolution are interspersed and modulated by environmental and genetic factors. As a result of a series of etiopathogenic and environmental factors, lesions (plaques) develop with greater or lesser lipid content, collagen, elastic fibers, and calcium. The location and degree of development of atherosclerotic plaques give rise to different forms of atherosclerotic disease, which is characterized by symptoms and signs that correspond to the obstruction of the vascular lumen with decreased flow and the consequent occurrence of (possibly chronic) ischemia. Atherosclerotic disease can also be characterized by the rupture of the plaque and the appearance of thrombotic phenomena (because the lipid nucleus of the plaque is highly thrombogenic and triggers the activation of the coagulation and platelet adhesion and aggregation cascades), with manifestations of acute ischemia.

The relationship between the composition of the atheroma plaque and the occurrence of cardiovascular events, revealed the need for imaging techniques that could identify not only the degree of stenosis of atherosclerotic lesions, but also their volume, composition and levels of inflammation, and thus being able to identify the possible high-risk plaques (vulnerable plaques). Within imaging techniques, there are invasive ones such as coronary angiography or coronary angiography, ultrasound or intravascular ultrasound (IVUS) and optical coherence tomography (OCT); and non-invasive, such as magnetic resonance imaging (MRI), positron emission tomography (PET), and computed tomography.

Invasive coronary angiography has traditionally been the reference imaging test to determine the degree of stenosis and continues to be the procedure of choice for the evaluation of coronary anatomy and the identification of atherosclerotic lesions. Angiography provides information on the number and size of vascular stenosis but does not allow to know the plaque composition. Provides Simply an image of the internal arterial lumen but lacks the ability to adequately represent the vessel wall with its developing atherosclerotic plaque.

Intravascular ultrasound (IVUS) is considered the reference method for the evaluation of atherosclerotic plaque burden and plaque characteristics. However, IVUS is an invasive method that has risks, cannot be used to study the entire coronary tree, only in one segment of the arterial tree and is not indicated for asymptomatic individuals.

The IVUS technique plus virtual histology allows the identification of atheroma plaques in the vascular tree, and can quantify the size, volume, composition and distribution of the plaque. However, a limitation of this technique is the ability of the ultrasound signal to penetrate the calcified tissue, resulting in an acoustic shadow after the calcified tissue.

Currently, with the new advances in the development of cardiac imaging techniques, coronary computed tomographic angiography (CCTA) has been incorporated as a non-invasive and easily applied method for direct visualization of coronary arteries without the need to introduce a catheter The image study of the coronary vessels by CCTA has been proposed as a suitable method for the qualitative detection of changes in the vessel wall, allowing the evaluation of the coronary arteries and the characterization of the atherosclerotic plaque.

In the last decade, several advances have been seen in CCTA that have made it one of the key diagnostic instruments for the non-invasive evaluation of coronary atherosclerosis in patients with a low to intermediate probability of coronary heart disease. CCTA may be useful for prognostic classification together with classic CVRF in patients with intermediate cardiovascular risk, for more accurate reclassification and as a screening for the early diagnosis of coronary atherosclerotic disease in certain groups of patients at special risk.

Previous studies have shown that CCTA is comparable to IVUS for the classification of atheroma plaques. CCTA, therefore, emerges as a non-invasive alternative for plaque characterization compared to other techniques such as IVUS.

Coronary CCTA has established itself as a reliable and accurate tool for the detection of coronary atherosclerotic plaque and stenosis. Since CCTA provides information about plaque burden and the characteristics of high-risk plaques, the addition of these parameters to the traditional interpretation of CCTA, which is limited to the detection of stenosis, could improve the efficiency of this method for the early detection of coronary heart disease.

Plaque characteristics are usually analyzed in a qualitative (subjective) way. This limitation can be solved through the use of new analytical platforms that allow automated quantification of the characteristics of the coronary plaque with high accuracy and reproducibility. In this context, software tools have been developed for the automated quantification of atheroma plaques in CCTA images. In this area, the QAngio CT (Medis medical imaging system, the netherlans) stands out, a software tool designed to perform quantitative analysis of images in CCTA data sets. In the CCTA data sets, the software is able to detect the contours of the vessel wall and the lumen, which are used for automated quantitative evaluations of coronary plaques. As for the characterization of the atherosclerotic plaque, the software is able to analyze virtual histology, differentiating between what is the mean, fibrous plaque, fibro-fatty, necrotic and calcified, with its consequent prognostic implication. The parameters of the entire coronary tree are obtained independently: vessel length, plaque burden, plaque volume, maximum thickness of the plaque, volume and percentage of fibrous plaque, fibro-fatty plaque, necrotic plaque and calcium plaque, maximum stenosis by area and by diameter. This software tool has a number of advantages over the analysis based on the IVUS. First, the non-invasiveness of the CCTA technique based on which this tool performs quantitative plaque analysis allows a consecutive analysis with a lower risk than that of IVUS. In addition, previous studies have demonstrated the correlation between QAngio CT and IVUS-based analysis regarding the area of lumen stenosis, plaque burden and remodeling index. On the other hand, although IVUS is the reference method for plaque quantification, it has the limitation of analyzing only a specific segment of the coronary tree, while QAngio CT allows the complete analysis of the coronary tree. In an evaluation study of atheroma plaque, this method could provide information not only on the size of the plaque, but also on the characteristics of the plaque.

The change in plaque volume has been used successfully to monitor plaque progression in studies with IVUS. Using IVUS, plaque volumes are calculated as the difference between the area of the outer elastic membrane and the lumen area for successive cross sections of a coronary artery. The difference between the volume of the vessel and the volume of the lumen constitutes the total volume of the plaque. From these volumes, other parameters such as the plaque burden or percentage of atheroma volume (PVA) or the total volume of atheroma (VTA) can be derived, being PVA the most reproducible and the molt related to cardiovascular prognosis.

Furthermore, recent studies have correlated the evaluation of the radiographic characteristics of plaque (Virtual histology) with the patient's prognosis. The QAngio CT provides an automated evaluation of the characteristics of the complete coronary tree plate based on radiological densities.

The prevention and treatment of DM2 should be considered an essential part of atherosclerotic disease. Throughout numerous and extensive clinical trials, it has been shown that reductions in blood glucose and HbA1c levels lead to reductions in cardiovascular risks. This knowledge suggests that atherosclerosis can be influenced by DM2 treatment.

Numerous studies have shown the beneficial effects of Glucagon-like peptide-1 (GLP-1) in the control of different cardiovascular pathologies and other effects beyond glycemic control, such as high blood pressure, weight control, and lipid metabolism. In addition to effects that are tangible in clinical practice, drugs that affect GLP-1 have been shown to have anti-atherosclerotic effects, due to the control of VR factors, or direct effects at the endothelial level. GLP-1-mediated decreases in atherosclerosis biomarkers, e.g., B-type natriuretic peptide (BNP), plasminogen activator inhibitor (PAI-1) and C- reactive protein (PCR), among others, have been observed. One of the parameters studied to validate this improvement in the progression of atherosclerosis has been the improvement in the control of the thickness of the carotid intima, which has clear benefits; however, studies in other vascular beds, such as the coronary, are more limited in terms of both numbers of participants and results.

The effect of semaglutide, a GLP-1 agonist, on the progression of atheroma plaque lesions has been published. Studies in animal models have shown that semaglutide treatment reduced progression by anti-inflammatory mechanisms, independent of weight loss and glycemic control. Semaglutide treatment in SUSTAIN6, as well as liraglutide treatment in LEADER, showed a benefit against placebo in major adverse cardiac events (MACE) (HR [95% confidence interval (CI)]: 0.87 [0.78; 0.97] LEADER and 0.74 [0.58; 0.95] SUSTAIN 6) in patients with atherosclerotic disease with or without previous ischemic events. The authors can affirm, after reviewing the literature, that the effect of GLP-1 on atheroma plaque is not definitively known but instead speculated on based on results in animal models and derived, to a large extent, from cardiovascular findings in clinical trials.

02

Conditions studied

  • Atheroscleroses, Coronary
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's planned enrollment of 120 is close to the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 at the initial screening visit between 8 and 10%
  • Coronary CT performed less than 3 months before starting study medication

Exclusion criteria

Exclusion Criteria:

  • heart disease
  • (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 \< 60 ml/min/1.73m2
  • History of
  • 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 must be willing to use an acceptable method(s) of during treatment and for an additional 15 weeks after the end of treatment
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Semaglutide

    Patients on semaglutide

    Drug: Semaglutide

Interventions

  • Usual treatment with semaglutide. Dose 0.5 - 1mg weekly, subcutaneous, weekly

06

What researchers measure

Primary outcomes

  1. Plaque burden modification assessed by coronary CT and plaque quantification

    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

    Time frame: 18 months

Secondary outcomes

  1. Atheroma volume modification assessed by coronary CT and plaque quantification

    Evaluate the effect of Semaglutide on the change in normalized total atheroma volume

    Time frame: 18 months

  2. Percentage of patients with significant plaque regresion assessed by coronary CT

    Percentage of patients who demonstrated significant plaque regression

    Time frame: 10 months

  3. Changes in composition of artery wall assessed by coronary CT and plaque quantification

    Effect of Semaglutide on the composition and architecture of the coronary artery wall

    Time frame: 18 months

  4. Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

    Time frame: 18 months

  5. Incidence of cardiovascular events

    Incidence and type of cardiovascular events (cardiovascular death, Acute coronary syndrome and stroke) during treatment with Semaglutide.

    Time frame: 18 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05071417
Lead sponsor
Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León
Responsible party
PM1-SEPLA IBSAL (Professor, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León) — Principal investigator
First posted
Oct 8, 2021
Start date
Nov 2021 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2025 (estimated)
Last update
Oct 8, 2021

Study contacts

Leopoldo Pérez de Isla, MD
Contact
leopisla@hotmail.com
+34609084225
Leopoldo Pérez de Isla
study director · Hospital Clínico San Carlos. Madrid. Spain.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Semaglutide

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