DelfaGLP-1 Atlas

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Sema-RMA

Not yet recruitingPhase NA

Semaglutide's Effect on Renal Hemodynamics and Function in Patients With Type 2 Diabetes Mellitus and Nephropathy

Glucagon-like Peptide-1's Effect on Renal Regional Blood Flow and the Renal Function in Patients With Type 2 Diabetes Mellitus

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

15

estimated

Study population

Chronic kidney disease, Type 2 diabetes

Key I/E criteria

•HbA1c ≥6.5%•eGFR 30-60•UACR ≥30•Male

Primary endpoints

•Total blood flow•Regional renal perfusion

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 IDNCT06555146
Org study IDH-20036378

Timeline

Milestones

Study first posted2024-08-15actual
Last update posted2024-08-15actual
Study start2024-08estimated (month precision)
Primary completion2025-03estimated (month precision)
Study completion2025-03estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Chronic kidney diseaseType 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age60 Years
SexMale
Healthy volunteersNot accepted

Inclusion criteria

•Type 2 diabetes mellitus diagnosed through either HbA1c ≥6,5% but ≤8,5%, or <6,5% combined with either fasting plasma glucose ≥7,0 mmol/L or plasma glucose ≥11,1 mmol/L two hours after an oral glucose tolerance test (OGTT).
•Estimated glomerular filtration rate (eGFR, CKD-EPI) between 30-60 mL/min/1.73m2
•Urine Albumin:Creatinine ratio (UACR) ≥30mg/g
•Stable RAAS blockade (ACE inhibitors or angiotensin II receptor blocker (ARB) with stable dosis for 4 weeks prior to screening)
•Discontinuation of treatment with selective sodium glucose transporter inhibitors (SGLT2i), dipeptidyl peptidase 4 inhibitors (DPP-4i), GLP-1R analogs, rapid-acting and mix insulin 30 days before screening.

Exclusion criteria

•Immunosuppressive therapy within 30 days of screening
•Alcohol abuse
•Medical treatment with glucocorticoids
•Kidney transplantation
•Treatment for renal failure with dialysis
•Myocardial infarction within 3 months of screening
•Heart failure (NYHA 3-4)
•Dysregulated arterial hypertension (systolic blood pressure ≥180 mm Hg or diastolic blood pressure ≥ 100 mm Hg)
•Liver disease (ALAT >2 x normal value)
•Conditions which may interfere with the glucose metabolism according to the PI
•Severe claustrophobia
•Elements incompatible with MRI
•Abnormal kidney size and/or position
•Venous and arterial anatomy hindering catheterization.

Endpoints (7)

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

Renal / kidney
3
Cardiometabolic biomarkers
3
Other (unclassified)
1

Renal / kidney

3 endpoints
Primary/protocol endpoint/low confidence

Regional renal perfusion

Time frame:Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)

descriptive

Secondary/protocol endpoint

Glomerular filtration rate

Time frame:Measured with Tec99-DTPA clearance. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year)

descriptive

Secondary/protocol endpoint

Sodium excretion in urine

Time frame:One measurement will be done on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)

concentration, descriptive

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint/low confidence

Activation of the renin angiotensin aldosterone system

Time frame:Blood samples will be taken 3 times on each intervention day, a total of 6 measurements for each participant, over the span of the study (approximately 1 year)

concentration, descriptive

Secondary/protocol endpoint

Blood pressure

Time frame:Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)

descriptive

Secondary/protocol endpoint

Heart Rate

Time frame:Measured continuously during a 60 minute period on each intervention day, a total of 2 measurements for each participant, over the span of the study (approximately 1 year)

Heart rate, change

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Total blood flow

Time frame:Measured during 30 minutes of MRI. One measurement will be done on each study day, a total of 4 measurements for each participant, over the span of the study (approximately 1 year).

descriptive

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.