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SIGNAL

Enrolling by invitationPhase 4

Urinary Proteomics to Guide Early Intervention to Prevent Complications in Type 2 Diabetes - a Feasibility Study

SIGNAL - Body Fluid Proteome SIGnatures for persoNALised Intervention to Prevent Cardiovascular and Renal Complications in Diabetes

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

50

estimated

Study population

Type 2 diabetes

Key I/E criterion

Primary endpoints

Proteomic feasibilityEvaluation of medical treatment

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 IDNCT06954090
Org study ID2024-518682-95
Secondary ID2024-518682-95-00

Timeline

Milestones

Study first posted2025-05-01actual
Study start2025-11-20actual
Last update posted2025-12-22actual
Primary completion2026-11-30estimated
Study completion2027-05-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Men and women over 18 years of age.

2. Type 2 diabetes with no clinical signs of HF NYHA Class IV

3. Able to understand the written participant information and give informed consent.

Exclusion criteria

1. Heart failure NYHA class IV at screening

2. Moderately - or severely increased albuminuria with a UACR ≥ 200 mg/g or CKD with an eGFR < 30 ml/min/1.73m2 at the screening visit.

3. A female who is pregnant, breastfeeding, or intends to become pregnant, or women of childbearing potential (WOCBP) who are not using highly effective contraceptive methods.

4. Receiving therapy with all three of the study medication prior to enrolment.

5. Myocardial infarction, unstable angina, stroke, or transient ischemic attack within 12 weeks prior to enrolment

6. Known or suspected hypersensitivity to the study medications or related products

7. History of pancreatitis at the screening visit

8. Body mass index < 18.5 kg/m2 at the screening visit

9. Type 1 diabetes

10. Serum potassium > 5.0 mmol/L at the screening visit

11. Addison's Disease

12. Concomitant treatment with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone)

13. Treatment with a potassium-sparing diuretic (amiloride, triamterene)

14. Treatment with other mineralocorticoid receptor antagonist than finerenone (e.g., spironolactone, eplerenone, esaxerenone, canrenone)

15. Elevated Alanine Aminotransferase (ALT) > 3x upper normal limit, autoimmune hepatitis, and/or severe hepatic impairment (including but not limited to a history of hepatic encephalopathy, a history of oesophageal varices or a history of portocaval shunt.)

16. Autosomal dominant or autosomal recessive polycystic kidney disease

17. Lupus nephritis or ANCA-associated vasculitis, or any other primary or secondary kidney disease requiring immunosuppressive therapy within 6 months prior to screening

18. Kidney transplant or dialysis

19. Presence or history of malignant neoplasms (except basal cell skin cancer or squamous cell skin cancer) within five years before screening.

20. Any other history, condition, therapy, or uncontrolled intercurrent illness that could, as judged by the investigator, affect participant safety or compliance with study requirements.

21. Known or suspected abuse of narcotics.

22. Participant in another intervention study,

23. Vulnerable (i.e., under guardianship) or mentally incapacitated subjects (i.e., not able to understand and sign the informed consent)

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

Other (unclassified)
3
Renal / kidney
2

Renal / kidney

2 endpoints
Secondary/protocol endpoint

Urine Albumin-to-Creatinine Ratio

Time frame:Over the 6 month of the follow up from screening visit to the end of study.

uACR, change

change from baseline, improvement

LOINC 9318-7

Secondary/protocol endpoint/low confidence

Urinary proteomic signatures

Time frame:Over the 6 month of the follow up from screening visit to the end of study.

change from baseline, improvement

Other (unclassified)

3 endpoints
Primary/protocol endpoint/low confidence

Proteomic feasibility

Time frame:2 weeks from sampling

threshold achievement, descriptive

Primary/protocol endpoint

Evaluation of medical treatment

Time frame:3 weeks from sampling

threshold achievement, descriptive

Other/protocol endpoint/low confidence

Assessment of health economics

Time frame:6 months from all participent data is collected

descriptive

Publications (10)

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.