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NATRIURETIC
UnknownPhase 2Incretin and Treatment With Inhibition of Sodium-glucose Cotransporter-2 Combination Insights Into Mechanisms Implicated in Congestive Heart Failure: "NATRIURETIC" Trial
Lead sponsor
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 18.5-40•HbA1c 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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
1 endpointBody 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 endpointsProximal tubular natriuresis
Time frame:up to 12 weeks
ratio, descriptive
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 endpointsSystolic 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
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
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 endpointsUrinary 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
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
- Journal of the American Heart Association2025 Mar 4PMID40008510doi:10.1161/JAHA.124.039129via pubmed acronym asset candidate
- Frontiers in cardiovascular medicine2025 (year)PMID41112222doi:10.3389/fcvm.2025.1633114via pubmed acronym asset candidate
- International journal of medical sciences2025 (year)PMID40765557doi:10.7150/ijms.112264via pubmed acronym asset candidate
- Cardiovascular research2021 Jul 27PMID32871009doi:10.1093/cvr/cvaa256via pubmed acronym asset candidate
- Cardiovascular diabetology2020 Jul 6PMID32631360doi:10.1186/s12933-020-01088-3via pubmed acronym asset candidate
- Endocrine connections2018 Jan (month)PMID29295870doi:10.1530/EC-17-0327via pubmed acronym asset candidate
Provenance
Sources
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.