Trial Outcomes & Findings for Ertugliflozin: Cardioprotective Effects on Epicardial Fat (NCT NCT04167761)
NCT ID: NCT04167761
Last Updated: 2026-06-04
Results Overview
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.
COMPLETED
EARLY_PHASE1
61 participants
Time to collect tissue collected during surgery (up to 15 minutes)
2026-06-04
Participant Flow
Unit of analysis: Ertugliflozin-treated tissue samples
Participant milestones
| Measure |
Ertugliflozin (Treated Tissue)
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
Ertugliflozin: 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
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Overall Study
STARTED
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61 74
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Overall Study
Participants who contributed samples
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37 74
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Overall Study
COMPLETED
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37 74
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Overall Study
NOT COMPLETED
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24 0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ertugliflozin: Cardioprotective Effects on Epicardial Fat
Baseline characteristics by cohort
| Measure |
Ertugliflozin (Treated Tissue)
n=40 Ertugliflozin-treated tissue samples
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
Ertugliflozin: 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
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Age, Continuous
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56.93 years
STANDARD_DEVIATION 16.76 • n=18 Participants
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Sex: Female, Male
Female
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5 Participants
n=18 Participants
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Sex: Female, Male
Male
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13 Participants
n=18 Participants
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Region of Enrollment
United States
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18 participants
n=18 Participants
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BMI
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33.4 kg/m²
STANDARD_DEVIATION 7.38 • n=18 Participants
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PRIMARY outcome
Timeframe: Time to collect tissue collected during surgery (up to 15 minutes)Population: Participants with tissue samples analyzable with optimized assays for lipolysis
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.
Outcome measures
| Measure |
Mock (Control)
n=40 Ertugliflozin-treated tissue samples
Adipose tissue samples collected from participants were incubated without Ertugliflozin to serve as a control condition.
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Ertugliflozin (Treated Tissue)
n=40 Ertugliflozin-treated tissue samples
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
Ertugliflozin: 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
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Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility
Basal
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45 µmol/L/hr
Standard Deviation 10
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105 µmol/L/hr
Standard Deviation 10
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Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility
Isoproterenol-Stimulated
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65 µmol/L/hr
Standard Deviation 12
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120 µmol/L/hr
Standard Deviation 12
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Rate of Isoproterenol-Stimulated Lipolysis in Adipose Tissue Depots to Measure Metabolic Flexibility
Insulin-Suppressed
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85 µmol/L/hr
Standard Deviation 15
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135 µmol/L/hr
Standard Deviation 15
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SECONDARY outcome
Timeframe: Time to collect tissue collected during surgery (up to 15 minutes)Population: Participants with tissue samples analyzable with optimized assays for lipolysis
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.
Outcome measures
| Measure |
Mock (Control)
n=40 Ertugliflozin-treated tissue samples
Adipose tissue samples collected from participants were incubated without Ertugliflozin to serve as a control condition.
|
Ertugliflozin (Treated Tissue)
n=40 Ertugliflozin-treated tissue samples
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
Ertugliflozin: 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
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Cytokine Secretion Profiles in Adipose Tissue Depots
TNFB (Explant)
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131 Mean Fluorescence Intensity (MFI)
Standard Deviation 18
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138 Mean Fluorescence Intensity (MFI)
Standard Deviation 12
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Cytokine Secretion Profiles in Adipose Tissue Depots
MCP1 (Adipocytes)
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30957 Mean Fluorescence Intensity (MFI)
Standard Deviation 15887
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22352 Mean Fluorescence Intensity (MFI)
Standard Deviation 16001
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Cytokine Secretion Profiles in Adipose Tissue Depots
IFN-G (Explant)
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159 Mean Fluorescence Intensity (MFI)
Standard Deviation 34
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179 Mean Fluorescence Intensity (MFI)
Standard Deviation 34
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Cytokine Secretion Profiles in Adipose Tissue Depots
IL1-B (Explant)
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449 Mean Fluorescence Intensity (MFI)
Standard Deviation 578
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836 Mean Fluorescence Intensity (MFI)
Standard Deviation 1055
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Cytokine Secretion Profiles in Adipose Tissue Depots
MCP1 (Explant)
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37370 Mean Fluorescence Intensity (MFI)
Standard Deviation 6873
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39405 Mean Fluorescence Intensity (MFI)
Standard Deviation 4011
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Cytokine Secretion Profiles in Adipose Tissue Depots
IL-6 (Explant)
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51035 Mean Fluorescence Intensity (MFI)
Standard Deviation 3206
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51923 Mean Fluorescence Intensity (MFI)
Standard Deviation 2451
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Cytokine Secretion Profiles in Adipose Tissue Depots
IFN-G (Adipocytes)
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134 Mean Fluorescence Intensity (MFI)
Standard Deviation 523521
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114 Mean Fluorescence Intensity (MFI)
Standard Deviation 52
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Cytokine Secretion Profiles in Adipose Tissue Depots
IL1-B (Adipocytes)
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281 Mean Fluorescence Intensity (MFI)
Standard Deviation 594
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266 Mean Fluorescence Intensity (MFI)
Standard Deviation 491
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Cytokine Secretion Profiles in Adipose Tissue Depots
TNFB (Adipocytes)
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132 Mean Fluorescence Intensity (MFI)
Standard Deviation 52
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125 Mean Fluorescence Intensity (MFI)
Standard Deviation 57
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Cytokine Secretion Profiles in Adipose Tissue Depots
IL-6 (Adipocytes)
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35904 Mean Fluorescence Intensity (MFI)
Standard Deviation 19154
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29682 Mean Fluorescence Intensity (MFI)
Standard Deviation 20958
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SECONDARY outcome
Timeframe: Time to process tissue samples collected during surgery (up to 15 minutes).Population: There were no analyzable aliquots remaining to be allocated to this analysis, all aliquots were allocated for analysis of the primary outcome measures. Additional aliquots cannot be obtained, therefore it is not possible to obtain or report data for this outcome measure.
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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Time to collect tissue collected during surgery (up to 15 minutes)Expression of genes related to inflammation and lipid metabolism (e.g., MCP1, TNF-β, IL-6) was measured in adipose tissue samples using mRNA extraction and RT-PCR after Ertugliflozin treatment. Analysis was performed to evaluate molecular changes in adipose depots (epicardial, pericardial, and subcutaneous).
Outcome measures
Outcome data not reported
Adverse Events
Ertugliflozin (Treated Tissue)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place