InflammationEarly Phase 1EFSIINCT06812429
Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation
A Early Phase 1 study testing Dapagliflozin (DAPA) in people with Inflammation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Dapagliflozin (DAPA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2024to 5 Apr 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: ≥18
- Patient has no prior history or use of Sodium-Glucose Co-transporter 2 Inhibitors.
- Women who are surgically sterilized, amenorrheic for a year, on long-term contraceptives like intrauterine devices and implantable and injectable contraceptives.
- Willing and able to complete the outcome assessments.
Who cannot join
- History of cardiac diseases (Heart Failure, NSTEMI/STEMI, cardiomyopathies, myocarditis).
- Diagnosis of Type I Diabetes Mellitus.
- Symptomatic hypotension (symptoms of hypotension + Systolic blood pressure < 90).
- Estimated glomerular filtration rate <25 mL/minute/1.73 m2, with renal function test done within a year from the study enrollment date.
- Alcohol use disorder as defined by the NIAAA or use of controlled substances or smoking cigarettes.
- History of dapagliflozin or other Sodium-Glucose Co-transporter 2 Inhibitor sensitivity.
- Other concomitant disease or condition that the investigator deems unsuitable for the study, including psychiatric, behavioral, or cognitive disorders, sufficient to interfere with the patient's ability to understand and comply with the study instructions or follow-up procedures.
- Women who are pregnant or intend to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation.
- Conditions
- Inflammation
- Being tested
- Dapagliflozin (DAPA)
- Keywords
- SGLT2 inhibitors, Dapagliflozin, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin (DAPA)Drug
Participants will receive 10mg of Dapagliflozin per day for three days.
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin group | Experimental | Participants in this arm receive dapagliflozin 10mg for three days. Receives: Drug: Dapagliflozin (DAPA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the markers of Inflammation at three days
Measured: From enrollment to the end of treatment at 3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start8 May 2024
- Primary completion5 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amanda Verma, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812429
- Sponsor's protocol ID
- 202401169
- Acronym
- EFSII
- Status last verified
- Jan 2026
- First submitted
- 1 Feb 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
USE OF SGLT2 INHIBITORS IN THE MANAGEMENT OF PATIENTS WITH HEART FAILURE POCKET GUIDE.
Bonnet F, Scheen AJ. Effects of SGLT2 inhibitors on systemic and tissue low-grade inflammation: The potential contribution to diabetes complications and cardiovascular disease. Diabetes Metab. 2018 Dec;44(6):457-464. doi: 10.1016/j.diabet.2018.09.005. Epub 2018 Sep 26.
PubMed 30266577Cardiac And Kidney Benefits Of Dapagliflozin Are Associated With ApoM Levels In Patients With Heart Failure With Reduced Ejection Fraction
Cowie MR, Fisher M. SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control. Nat Rev Cardiol. 2020 Dec;17(12):761-772. doi: 10.1038/s41569-020-0406-8. Epub 2020 Jul 14.
PubMed 32665641Chirinos JA, Zhao L, Jia Y, Frej C, Adamo L, Mann D, Shewale SV, Millar JS, Rader DJ, French B, Brandimarto J, Margulies KB, Parks JS, Wang Z, Seiffert DA, Fang J, Sweitzer N, Chistoffersen C, Dahlback B, Car BD, Gordon DA, Cappola TP, Javaheri A. Reduced Apolipoprotein M and Adverse Outcomes Across the Spectrum of Human Heart Failure. Circulation. 2020 May 5;141(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.045323. Epub 2020 Apr 2.
PubMed 32237898
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Sodium-Glucose Co-transporter 2 Inhibitors on Inflammation
- ClinicalTrials.gov ID
- NCT06812429
- Acronym / sponsor ID
- EFSII / 202401169
- Conditions
- Inflammation
- Keywords
- SGLT2 inhibitors, Dapagliflozin, Inflammation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 8 May 2024 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The research aims to understand how a specific type of medication called Sodium-glucose co-transporter 2 (SGLT2) inhibitors affect cardiorenal inflammation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin group | Experimental | Drug: Dapagliflozin (DAPA)Participants in this arm receive dapagliflozin 10mg for three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: ≥18
- Patient has no prior history or use of Sodium-Glucose Co-transporter 2 Inhibitors.
- Women who are surgically sterilized, amenorrheic for a year, on long-term contraceptives like intrauterine devices and implantable and injectable contraceptives.
- Willing and able to complete the outcome assessments.
Key exclusion criteria (8 listed)
- History of cardiac diseases (Heart Failure, NSTEMI/STEMI, cardiomyopathies, myocarditis).
- Diagnosis of Type I Diabetes Mellitus.
- Symptomatic hypotension (symptoms of hypotension + Systolic blood pressure < 90).
- Estimated glomerular filtration rate <25 mL/minute/1.73 m2, with renal function test done within a year from the study enrollment date.
- Alcohol use disorder as defined by the NIAAA or use of controlled substances or smoking cigarettes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin (DAPA)Participants will receive 10mg of Dapagliflozin per day for three days. | Drug | Dapagliflozin group |
Primary outcome
Change from baseline in the markers of Inflammation at three days
Time frame: From enrollment to the end of treatment at 3 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- BackgroundUSE OF SGLT2 INHIBITORS IN THE MANAGEMENT OF PATIENTS WITH HEART FAILURE POCKET GUIDE.
- Background: PubMed 30266577Bonnet F, Scheen AJ. Effects of SGLT2 inhibitors on systemic and tissue low-grade inflammation: The potential contribution to diabetes complications and cardiovascular disease. Diabetes Metab. 2018 Dec;44(6):457-464. doi: 10.1016/j.diabet.2018.09.005. Epub 2018 Sep 26.
- BackgroundCardiac And Kidney Benefits Of Dapagliflozin Are Associated With ApoM Levels In Patients With Heart Failure With Reduced Ejection Fraction
- Background: PubMed 32665641Cowie MR, Fisher M. SGLT2 inhibitors: mechanisms of cardiovascular benefit beyond glycaemic control. Nat Rev Cardiol. 2020 Dec;17(12):761-772. doi: 10.1038/s41569-020-0406-8. Epub 2020 Jul 14.
- Background: PubMed 32237898Chirinos JA, Zhao L, Jia Y, Frej C, Adamo L, Mann D, Shewale SV, Millar JS, Rader DJ, French B, Brandimarto J, Margulies KB, Parks JS, Wang Z, Seiffert DA, Fang J, Sweitzer N, Chistoffersen C, Dahlback B, Car BD, Gordon DA, Cappola TP, Javaheri A. Reduced Apolipoprotein M and Adverse Outcomes Across the Spectrum of Human Heart Failure. Circulation. 2020 May 5;141(18):1463-1476. doi: 10.1161/CIRCULATIONAHA.119.045323. Epub 2020 Apr 2.
- Individual participant dataSharing planned: Yes
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dapagliflozin (DAPA) in people with Inflammation, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the markers of Inflammation at three days (time frame: From enrollment to the end of treatment at 3 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06812429, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.