Cardiovascular DiseasesEarly Phase 1NCT04167761
Ertugliflozin: Cardioprotective Effects on Epicardial Fat
A Early Phase 1 study testing Ertugliflozin in people with Cardiovascular Diseases and Atherosclerosis, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Atherosclerosis, Type 2 Diabetes
- What is being tested?
- Ertugliflozin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 31 Dec 2023
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery or vascular surgery
- history of Diabetes Mellitus Type 2 currently diet controlled, or on metformin or dpp4 inhibitors
Who cannot join
- allergy or intolerance to interventional medication
- currently taking insulin, glp-1 inhibitors, or sulfonylureas
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.
- Being tested
- Ertugliflozin
- Keywords
- Epicardial Adipose Tissue, SGLT2 Inhibitor
- Medical subject headings
- Cardiovascular Diseases, Atherosclerosis, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErtugliflozinDrug
Also called SGLT2 inhibitor
Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue
| Study group | Role | What they receive |
|---|---|---|
| Ertugliflozin (treated tissue) | Experimental | Adipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues Receives: Drug: Ertugliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility
The rate of lipolysis was measured under basal, isoproterenol-stimulated, and insulin-suppressed conditions in adipose tissue depots (epicardial, pericardial, and subcutaneous) treated with and without Ertugliflozin. Lipolysis was quantified using a colorimetric assay to determine metabolic flexibility. Cardiac adipose tissue explants cultured with ertugliflozin compared to mock condition.
Measured: Time to collect tissue collected during surgery (up to 15 minutes)
Secondary outcomes (2)
Cytokine Secretion Profiles in Adipose Tissue Depots
Levels of cytokines, including MCP1, TNF-β, IL-6, IFN-γ, and IL1-β, were measured in the culture medium of treated and untreated adipose tissue depots (epicardial, pericardial, and subcutaneous) using Luminex assays. Cytokine levels were used to characterize inflammation and response to Ertugliflozin treatment in cardiac adipose tissue explants) and isolated adipocytes after culture with Ertugliflozin vs mock condition.
Measured: Time to collect tissue collected during surgery (up to 15 minutes)
Adipose Cell Size Distribution in Pericardial and Subcutaneous Tissue
Adipose cell size distribution was assessed in subcutaneous and pericardial adipose tissue samples using osmium fixation and cell diameter measurements. The relationship between cell size and Ertugliflozin treatment was analyzed.
Measured: Time to process tissue samples collected during surgery (up to 15 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start1 Jul 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Model description
- in vitro experimental study with treated and control tissue samples
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Tracey McLaughlin, Stanford University
- Investigators
- Tracey McLaughlin, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167761
- Sponsor's protocol ID
- 52647
- Status last verified
- Apr 2026
- First submitted
- 15 Nov 2019
- Last updated
- 4 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ertugliflozin: Cardioprotective Effects on Epicardial Fat
- ClinicalTrials.gov ID
- NCT04167761
- Acronym / sponsor ID
- 52647
- Keywords
- Epicardial Adipose Tissue, SGLT2 Inhibitor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Nov 2019 (actual)
- Results
- Posted 4 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn if Sodium-Glucose Cotransporter 2 inhibitor (SGLT2i) medications enhance beneficial properties of epicardial adipose tissue including metabolic flexibility, insulin sensitivity, decreased cell size and reduced inflammation.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- in vitro experimental study with treated and control tissue samples
| Arm | Type | Receives |
|---|---|---|
| Ertugliflozin (treated tissue) | Experimental | Drug: ErtugliflozinAdipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. Tissue samples were incubated with Ertugliflozin to evaluate its effects on lipolysis, inflammation, and gene expression in epicardial, pericardial, and subcutaneous adipose tissues |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patient at Stanford Cardiovascular Surgery clinic who is scheduled for cardiac bypass surgery or vascular surgery
- history of Diabetes Mellitus Type 2 currently diet controlled, or on metformin or dpp4 inhibitors
Key exclusion criteria (2 listed)
- allergy or intolerance to interventional medication
- currently taking insulin, glp-1 inhibitors, or sulfonylureas
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 |
|---|---|---|
| ErtugliflozinAlso: SGLT2 inhibitorAdipose tissue samples collected from participants were treated with Ertugliflozin at a concentration of 25 µM in vitro. This treatment was applied in a laboratory setting to assess the effects of Ertugliflozin on lipolysis, inflammatory cytokine release, and gene expression in epicardial, pericardial, and subcutaneous adipose tissue | Drug | Ertugliflozin (treated tissue) |
Primary outcome
Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility
Time frame: Time to collect tissue collected during surgery (up to 15 minutes)
The rate of lipolysis was measured under basal, isoproterenol-stimulated, and insulin-suppressed conditions in adipose tissue depots (epicardial, pericardial, and subcutaneous) treated with and without Ertugliflozin. Lipolysis was quantified using a colorimetric assay to determine metabolic flexibility. Cardiac adipose tissue explants cultured with ertugliflozin compared to mock condition.
2 secondary outcomes
Cytokine Secretion Profiles in Adipose Tissue Depots
Time frame: Time to collect tissue collected during surgery (up to 15 minutes)
Adipose Cell Size Distribution in Pericardial and Subcutaneous Tissue
Time frame: Time to process tissue samples collected during surgery (up to 15 minutes).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tracey McLaughlin, MD principal investigator
Stanford University
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 Ertugliflozin in people with Cardiovascular Diseases and Atherosclerosis, run by Stanford University 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 2 inclusion and 2 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 4 Jun 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?
Yes. Results are posted in the registry (first posted 4 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility (time frame: Time to collect tissue collected during surgery (up to 15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2026.