DelfaGLP-1 Atlas

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CompletedPhase 1

A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes

A Trial Investigating the Effect of Semaglutide on Atherosclerosis in Patients With Cardiovascular Disease and Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

4

Recruiting sites

—

Enrollment

101

actual

Study population

Cardiovascular disease, Type 2 diabetes

Key I/E criteria

•BMI ≤39.9•Established CVD•HbA1c 6-9%

Primary endpoint

•Maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG)

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 IDNCT04032197
Org study IDNN9535-4430
Secondary ID2018-002289-38European Medicines Agency (EudraCT)
Secondary IDU1111-1215-4058World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-07-25actual
Study start2019-08-12actual
Primary completion2022-12-16actual
Study completion2023-06-06actual
Last update posted2025-04-29actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Cardiovascular diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age above or equal to 50 years at the time of signing informed consent
•Body mass index equal to or less than 39.9 kg/m^2
•Diagnosed with type 2 diabetes 180 daysor more prior to the day of the first screening visit
•HbA1c 6.0% - 9.0% (42-75 mmol/mol) (both inclusive)
•Established cardiovascular disease

Exclusion criteria

•Hospitalisation for unstable angina pectoris or transient ischaemic attack within 90 days prior to the day of the first screening visit
•Planned coronary, carotid or peripheral artery revascularisation.
•Presently classified as being in New York Heart Association (NYHA) equal to or above Class III
•Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or systemic anti-inflammatory drugs within 90 days prior to the first screening visit. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed

Endpoints (5)

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

Cardiometabolic biomarkers
4
Other (unclassified)
1

Cardiometabolic biomarkers

4 endpoints
Primary/protocol endpoint

Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries

Time frame:From baseline (from 41 days before randomisation) to week 26

change from baseline, improvement

Secondary/protocol endpoint

Change in total wall volume of the most diseased carotid artery

Time frame:From baseline (from 41 days before randomisation) to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery

Time frame:From baseline (from 41 days before randomisation) to week 52

change from baseline, improvement

Secondary/protocol endpoint

Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery

Time frame:From baseline (from 41 days before randomisation) to week 52

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries

Time frame:From baseline (from 40 days before randomisation) to week 26

change from baseline, improvement

Publications (1)

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.