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NATRIURETIC

UnknownPhase 2

Incretin and Treatment With Inhibition of Sodium-glucose Cotransporter-2 Combination Insights Into Mechanisms Implicated in Congestive Heart Failure: "NATRIURETIC" Trial

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

36

estimated

Study population

Type 2 diabetes

Key I/E criteria

BMI 18.5-40HbA1c 7-12%eGFR ≥30

Primary endpoint

Proximal tubular natriuresis

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 IDNCT04535960
Org study ID18-5058

Timeline

Milestones

Study start2019-01-24actual
Study first posted2020-09-02actual
Last update posted2023-05-17actual
Primary completion2023-10estimated (month precision)
Study completion2023-10estimated (month precision)

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 diagnosed with T2D ≥6 months prior to informed consent;

2. eGFR ≥30 mL/min/1.73m2;

3. Age >18 years;

4. HbA1c 7.0%-12.0%;

5. Body Mass Index (BMI) 18.5-40.0 kg/m2;

6. Stable HbA1c, measured 2-12 months prior to screening, within 5% of baseline value;

7. Blood pressure ≤160/100 mmHg at screening, >90/60 mmHg;

8. Stable on dose of ACE inhibitor, angiotensin receptor blocker or renin inhibitor for at least 2 weeks.

Exclusion criteria

1. Type 1 Diabetes;

2. Leukocyte and/or nitrite positive urinalysis that is untreated;

3. Severe hypoglycaemia within 2 months prior to screening;

4. History of hypoglycaemia unawareness based on investigator judgement;

5. Unstable coronary artery disease with acute coronary syndrome, percutaneous intervention or bypass surgery within 3 months;

6. Clinically significant valvular disease subject to PI/Sub PI's discretion;

7. Congestive heart failure subject to PI/Sub PI's discretion;

8. Bariatric surgery or other surgeries that induce chronic malabsorption within one year;

9. Anti-obesity drugs or diet regimen and unstable body weight three months prior to screening;

10. Treatment with systemic corticosteroids;

11. Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells;

12. Pre-menopausal women who are nursing, pregnant, or of child-bearing potential and not practicing an acceptable method of birth control;

13. Participation in another trial with an investigational drug within 30 days of informed consent;

14. Alcohol or drug abuse within three months prior to informed consent that would interfere with trial participation or any ongoing clinical condition that would jeopardize subject safety or study compliance based on investigator judgement;

15. Liver disease, defined by serum levels of alanine transaminase, aspartate transaminase, or alkaline phosphatase >3 x upper limit of normal as determined during screening;

16. Medical history of cancer or treatment for cancer in the last five years prior to screening;

17. History of pancreatitis;

18. Personal of family history of medullary thyroid cancer or MEN2B;

19. Tachycardia, HR >100;

20. Use of SGLT2i, GLP-1RA or DPP-4i within the past 1 month (1-month minimum washout is allowed);

21. History of gastroparesis;

22. Known intolerance to SGLT2i or GLP-1RA;

23. Allergy to iodine-based substances if receiving iohexol for GFR measures.

Endpoints (8)

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
3
Renal / kidney
2
Other (unclassified)
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Body weight

Time frame:Body weight will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)

Body weight, absolute change (kg)

change from baseline, improvement

Renal / kidney

2 endpoints
Primary/protocol endpoint

Proximal tubular natriuresis

Time frame:up to 12 weeks

ratio, descriptive

Secondary/protocol endpoint

Glomerular Filtration Rate

Time frame:Glomerular Filtration Rate (GFR, based on plasma iohexol clearance) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Systolic blood pressure

Time frame:Systolic blood pressure (SBP) will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Arterial stiffness

Time frame:Arterial stiffness will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)

change from baseline, improvement

Secondary/protocol endpoint

Systemic vascular resistance

Time frame:Systemic vascular resistance will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)

change from baseline, improvement

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Urinary concentration of the renin-angiotensin aldosterone system (RAAS) markers

Time frame:Outcome will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)

concentration, descriptive

Secondary/protocol endpoint

Urinary EGF,FGF2,Eotaxin,TGFa,G-CSF,Flt-3L,GM-CSF,Fractalkine,IFNa2,IFNy,GRO,IL10,MCP-3,IL-12P40,MDC,IL-12P70,PDGF-AA,IL-13,PDGF-BB,IL-15,sCD40L,IL-17A,IL-1RA,IL1a,IL9,IL1B,IL2,IL3,IL4,IL5,IL6,IL7,IL8,IL10,MCP-1,MIP-1a,MIP-1B,RANTES,TNFalpha,TNFB,VEGF

Time frame:Outcome will be measured at 2 time points: monotherapy (6 weeks) and combination therapy (12 weeks)

concentration, 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.