DelfaGLP-1 Atlas

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CASCADES

RecruitingPhase 4

Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

A Randomized, Open-label, Clinical Trial Evaluating the Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

300

estimated

Study population

Cardiovascular disease, Prediabetes / glucose intolerance

Key I/E criterion

—

Primary endpoint

•Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07254572
Org study IDCSDS.IV/VIII/2023

Timeline

Milestones

Study start2025-07-10actual
Study first posted2025-11-28actual
Last update posted2025-11-28actual
Primary completion2029-08-01estimated
Study completion2029-08-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseasePrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age 18 - 80
•Diagnosed coronary artery disease (coronary artery stenosis of at least 20% with a reference diameter of >2.5 mm or status after percutaneous coronary revascularization procedure found on coronary CT scan)
•Coronary CT scan performed <3 months after inclusion in the study, at least of good quality
•Pre-diabetic status defined as fasting blood glucose 100-125 mg% or Hba1c 5.70-6.49% (measurement documented at the screening/randomization appointment or within 30 days prior to the screening/randomization appointment) or documented, positive result of an oral glucose load test (fasting blood glucose 100-125 mg% and 140-199 mg% 2h after a 75 g oral glucose load) performed up to 30 days before the screening/randomization appointment
•Stable treatment and control of cardiovascular risk factors, including dietary and lifestyle management for at least 4 weeks
•Willing and able to give informed consent to participate in the study
•Willing and able, according to the researcher, to comply with all the requirements of the study

Exclusion criteria

•Severe valvular defect
•Clinical condition requiring surgical treatment of coronary artery disease
•Status after coronary artery bypass surgery
•Diagnosed diabetes or Hba1c>=6.5% at screening/randomization appointment
•Other severe medical conditions requiring scheduled hospital treatment at the time of the study
•Severe musculoskeletal conditions requiring specific rehabilitation recommendations
•Diagnosed heart failure
•Presence of an artificial valve, cardiac pacing system or other implantable device (such as a cardioverter defibrillator)
•Severe arrhythmia/unexplained loss of consciousness
•Other contraindications to physical activity
•No consent to participate in the study
•Use of glucose-lowering drugs other than metformin
•Use of weight-loss drugs
•Condition after bariatric surgery
•Diagnosed liver disease or ALT, AST above three times the upper limit of normal at screening appointment
•Uncompensated hyperthyroidism
•Pancreatic cancer
•Medullary thyroid cancer
•History of anaphylactic shock after iodine contrast administration
•Chronic kidney disease (eGFR <45 ml/min/1.73 m2)
•History of pancreatitis or active pancreatitis
•Body mass index (BMI) >40 kg/m2
•Pregnancy/lactation
•Participation in another clinical trial
•Other known contraindications to treatment with metformin, dapagliflozin or semaglutide

Endpoints (31)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes
8
Weight & body composition
7
Cardiometabolic biomarkers
7
Glycemic / diabetes
3
Other clinical outcomes
3
Other (unclassified)
2
Heart failure
1

Cardiovascular outcomes

8 endpoints
Primary/protocol endpoint

Evaluation of the effect of GLP-1 analogue treatment on coronary artery disease progression AND Evaluation of the effect of flozin treatment on the progression of coronary artery disease (CO-PRIMARY ENDPOINTS)

Time frame:24 months

percent change from baseline, improvement

Secondary/protocol endpoint

Evaluation of the effect of each of the tested drugs vs. control group on progression of coronary artery disease

Time frame:24 months

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Comparison of the effect of semaglutide vs. flozin on coronary artery disease progression

Time frame:24 months

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease

Time frame:24 months

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease (plaque conversion)

Time frame:24 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk expressed as the dynamics of high-risk features

Time frame:24 months

change from baseline, improvement

Secondary/protocol endpoint

Number of unscheduled hospitalizations

Time frame:24 months

All-cause hospitalization

event count, event

Secondary/protocol endpoint

Number of major cardiovascular events and strokes (MACCE: death/myocardial infarction/revascularization/stroke) separately and combined

Time frame:24 months

Expanded / custom MACE composite

event count, event

componentsAll-cause death, Myocardial infarction (any), Coronary revascularization, Stroke (any)

Weight & body composition

7 endpoints
Secondary/protocol endpoint

Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body weight

Time frame:24 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body mass index

Time frame:24 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - total body fat

Time frame:24 months

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - body cell mass

Time frame:24 months

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - fat to mass ratio

Time frame:24 months

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - visceral fat area

Time frame:24 months

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of changes in anthropometric measurements in patients treated with semaglutide vs. patients treated with flozin - waist-to-hip index

Time frame:24 months

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Evaluation of change in the percentage of glycated hemoglobin (HbA1c) in patients treated with semaglutide vs. patients treated with flozin

Time frame:24 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Type 2 diabetes diagnosis

Time frame:24 months

T2DM prevention

threshold achievement, event

Secondary/protocol endpoint

Homeostatic Model Change Assessment - Insulin Resistance (HOMA-IR)

Time frame:12 and 24 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Heart failure

1 endpoint
Secondary/protocol endpoint

Evaluation of the onset of heart failure requiring hospitalization

Time frame:24 months

Heart-failure hospitalization

event count, event

SNOMED 84114007

Cardiometabolic biomarkers

7 endpoints
Secondary/protocol endpoint

Evaluation of the effect of each study drug vs. control group/comparison of the effect of semaglutide vs. flozin on progression of coronary artery disease

Time frame:24 months

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Evaluation of the effect of each of the tested drugs vs. control group/comparison of the effect of semaglutide vs. flozin on CV risk on pericoronary fat attenuation index

Time frame:24 months

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of change in inflammatory parameters in patients treated with semaglutide vs. patients treated with flozin

Time frame:24 months

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Evaluation of change in lipid levels in patients treated with semaglutide vs. patients treated with flozin

Time frame:24 months

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of change in the percentage of patients with normal blood pressure in patients treated with semaglutide vs. patients treated with flozin

Time frame:24 months

threshold achievement, improvement

Secondary/protocol endpoint

Evaluation of change in the concentration of selected oxidative stress markers - superoxide dismutase (SOD)

Time frame:12 months and 24 months

concentration, descriptive

Secondary/protocol endpoint/low confidence

Evaluation of change in the concentration of selected oxidative stress markers - Oxygen Radical Absorbance Capacity (ORAC)

Time frame:12 months and 24 months

change from baseline, improvement

Other clinical outcomes

3 endpoints
Secondary/protocol endpoint

Evaluation of change in the percentage of patients smoking tobacco or electronic cigarettes in patients treated with semaglutide vs. patients treated with flozin

Time frame:24 months

change from baseline, improvement

Secondary/protocol endpoint

Evaluation of compliance with physical activity recommendations in patients treated with semaglutide vs. patients treated with flozin

Time frame:24 months

categorical status, improvement

Secondary/protocol endpoint

Evaluation of dietary compliance in patients treated with semaglutide vs. patients treated with flozin

Time frame:24 months

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Evaluation of change in the concentration of selected oxidative stress markers - catalase

Time frame:12 months and 24 months

concentration, descriptive

Secondary/protocol endpoint/low confidence

Evaluation of change in the concentration of selected oxidative stress markers - total antioxidant capacity (TAC)

Time frame:12 months and 24 months

change from baseline, improvement

Publications (5)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.