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Delfa

← All trials/NCT05071417

SEPLA

UnknownPhase 3

Effect Of Semaglutide In Coronary Atheroma Plaque

Effect Of Semaglutide In Coronary Atherosclerotic Plaqus Assessed by Coronay CT

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

-

Estimated enrollment

120

Study population

Cardiovascular disease, Type 2 diabetes

Eligibility highlights

•HbA1c 8-10%

Primary endpoint

•Plaque burden modification

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05071417
Org study IDSEPLA

Timeline

Milestones

Study first posted2021-10-08actual
Last update posted2021-10-08actual
Study start2021-11estimated (month precision)
Primary completion2024-12estimated (month precision)
Study completion2025-12estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Who can enroll

Minimum age35 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (6)

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
3
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1
Other (unclassified)
1

Cardiovascular outcomes

3 endpoints
Secondary/protocol endpoint

Percentage of patients with significant plaque regresion assessed by coronary CT

Time frame:10 months

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:18 months

change from baseline, improvement

Secondary/protocol endpoint

Incidence of cardiovascular events

Time frame:18 months

Expanded / custom MACE composite

composite event, event

componentsCardiovascular death, Myocardial infarction (any), Stroke (any)

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Atheroma volume modification assessed by coronary CT and plaque quantification

Time frame:18 months

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

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

Time frame:18 months

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Plaque burden modification assessed by coronary CT and plaque quantification

Time frame:18 months

percent change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 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 6, 2026 snapshot.