DelfaGLP-1 Atlas

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Active not recruitingPhase 3

A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes

Long-term Effects of Semaglutide on Diabetic Retinopathy in Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

229

Recruiting sites

—

Enrollment

1,500

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS)

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 IDNCT03811561
Org study IDNN9535-4352
Secondary ID2017-003619-20European Medicines Agency (EudraCT)
Secondary IDU1111-1201-6256World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-01-22actual
Study start2019-05-08actual
Last update posted2026-04-30actual
Primary completion2027-11-07estimated
Study completion2027-11-07estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age greater than or equal to 18 years at the time of signing informed consent
•Diagnosed with type 2 diabetes mellitus.
•HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive).
•Eye inclusion criteria (both eyes must meet all criteria):
•Early Treatment Diabetic Retinopathy Study (ETDRS) level of 10-75 (both inclusive) evaluated by fundus photography and confirmed by central reading centre
•No ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema six months prior to the day of screening.
•No anticipated need for ocular or intraocular treatment for diabetic retinopathy or diabetic macular oedema within three months after randomisation.
•Best-corrected visual acuity greater than or equal to 30 letters using the ETDRS visual acuity protocol
•No previous treatment with pan-retinal laser photocoagulation
•No substantial non-diabetic ocular condition that, in the opinion of the ophthalmologist, would impact diabetic retinopathy or diabetic macular oedema progression during the trial
•No substantial media opacities that would preclude successful imaging

Exclusion criteria

•Any of the following: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
•Subjects presently classified as being in New York Heart Association (NYHA) Class IV
•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 30 ml/min/1.73 m^2
•Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
•Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive methods
•Concurrent treatment with any GLP-1 receptor agonist or DPP-4 inhibitor from randomisation.
•Receipt of any investigational medicinal product within 30 days before screening
•Previous participation in this trial. Participation is defined as randomisation
•Known or suspected hypersensitivity to trial products or related products
•Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Endpoints (22)

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

Other clinical outcomes
18
Cardiometabolic biomarkers
2
Weight & body composition
1
Glycemic / diabetes
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight.

Time frame:Week 0, Year 5

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change in glycosylated haemoglobin (HbA1c).

Time frame:Week 0, Year 5

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Change in systolic and diastolic blood pressure.

Time frame:Week 0, Year 5

change from baseline, improvement

Secondary/protocol endpoint

Change in Lipids: Total-cholesterol, High density lipoprotein (HDL)-cholesterol, low density lipoprotein (LDL)-cholesterol and triglycerides.

Time frame:Week 0, Year 5

change from baseline, improvement

componentsTotal cholesterol, change, HDL-C, change, LDL-C, change, Triglycerides, change

Other clinical outcomes

18 endpoints
Primary/protocol endpoint

Presence of at least 3 steps Early Treatment Diabetic Retinopathy Study (ETDRS) subject level progression.

Time frame:Year 5

categorical status, event

Secondary/protocol endpoint

Time from randomisation to first at least 3 steps ETDRS subject level progression or central involved diabetic macular oedema (ciDME) in either eye.

Time frame:Up to 5 years

time to event, event

Secondary/protocol endpoint

Change in visual acuity in the worse seeing eye.

Time frame:Week 0, Year 5

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in visual acuity in the better seeing eye.

Time frame:Week 0, Year 5

change from baseline, improvement

Secondary/protocol endpoint

Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with focal/grid laser photocoagulation.

Time frame:Week 0-Year 5

threshold achievement, event

Secondary/protocol endpoint

Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with pan-retinal laser photocoagulation.

Time frame:Week 0-Year 5

threshold achievement, event

Secondary/protocol endpoint

Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with anti-vascular endothelial growth factor (VEGF).

Time frame:Week 0-Year 5

threshold achievement, event

Secondary/protocol endpoint

Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with intravitreal injection with steroid.

Time frame:Week 0-Year 5

categorical status, event

Secondary/protocol endpoint

Occurrence of treatment for diabetic retinopathy or diabetic macular oedema in either eye with vitrectomy.

Time frame:Week 0-Year 5

threshold achievement, event

Secondary/protocol endpoint/low confidence

Presence of at least 3 steps ETDRS subject level improvement.

Time frame:Year 5

threshold achievement, improvement

Secondary/protocol endpoint

Presence of at least 2 steps ETDRS subject level progression.

Time frame:Year 5

categorical status, improvement

Secondary/protocol endpoint

Presence of at least 2 steps ETDRS subject level improvement.

Time frame:Year 5

threshold achievement, improvement

Secondary/protocol endpoint

Presence of persistent visual acuity up to 38 ETDRS letters in either eye.

Time frame:Year 5

categorical status, event

Secondary/protocol endpoint

Presence of persistent at least 2 lines (10 letters) ETDRS worsening in visual acuity in either eye from baseline.

Time frame:Year 5

categorical status, event

Secondary/protocol endpoint

Presence of persistent at least 3 lines (15 letters) ETDRS worsening in visual acuity in either eye from baseline.

Time frame:Year 5

categorical status, event

Secondary/protocol endpoint

Presence of persistent at least 2 lines (10 letters) ETDRS improvement in visual acuity in either eye from baseline.

Time frame:Year 5

threshold achievement, improvement

Secondary/protocol endpoint

Persistent at least 3 lines (15 letters) ETDRS improvement in visual acuity in either eye from baseline.

Time frame:Year 5

threshold achievement, improvement

Secondary/protocol endpoint

Presence of ciDME in either eye.

Time frame:Year 5

categorical status, event

Publications (17)

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.