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RecruitingNCT06506422ERASE-AgingUpdated Feb 6, 2026

Empagliflozin Reversal of Arterial StiffnEss in Aging

A Phase 2/3 interventional study of Empagliflozin 10 MG and Placebo in Aging and Arterial Stiffness, sponsored by University of Missouri-Columbia. Recruiting at 1 site in United States. Open to participants aged 60 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by University of Missouri-Columbia · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 1 month later.
Phase
Phase 2/3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study summary

Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.

Read the detailed description

The investigators will employ a double-blinded randomized placebo control trial to determine the effects of 12 weeks of sodium glucose co-transporter 2 (SGLT2) inhibition with empagliflozin (10 mg daily), or matching placebo. Empagliflozin has been shown to decrease cardiovascular events and arterial stiffness in different populations. Placebo will be included for comparison purposes as empagliflozin is not a standard therapy for aging-associated arterial stiffness.

02

Conditions studied

  • Aging
  • Arterial Stiffness
03

In context

Lead sponsor

University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Able to provide consent
  • 60 to 80 years of age at randomization (women must be postmenopausal defined as more than 1 year without menses)
  • Stable anti-hypertensive medication regimen (if in use) for at least 90 days
  • Evidence of arterial stiffening (defined as carotid-femoral PWV >/= 8 m/s) at the time of screening visit.

Exclusion criteria

Exclusion Criteria:

  • Diabetes
  • BMI>/= 45kg/m2
  • Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
  • Estimated glomerular filtration rate GFR \< 29 mL/min
  • Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
  • Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
  • Use of hormone replacement therapy
  • Body weight change ≥10% within the last 6 months
  • Uncontrolled hypertension during screening visit (>180/110 mmHg)
  • Symptomatic hypotension and/or a SBP \<100 mmHg
  • History of ketoacidosis
  • High fall risk per assessment of study physician and/or safety officer at the time of screening (results must be abnormal for both fall risk assessments and orthostatic blood pressure measurements)
  • Anticipated need of prolonged fasting
  • History of recurrent UTIs or mycotic genital infections
  • Following a low-carbohydrate diet (\<20 grams/day)
  • Participation in regular exercise > 3 days/week per week at a moderate or vigorous intensity
  • Known sensitivity to nitrate medications
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Empagliflozin

    10mg Empagliflozin daily for 12 weeks

    Drug: Empagliflozin 10 MG

  • Placebo comparator
    Placebo

    10mg Placebo daily for 12 weeks

    Drug: Placebo

Interventions

  • DrugEmpagliflozin 10 MG

    10mg Empagliflozin daily for 12 weeks

    Also known as: Active

  • DrugPlacebo

    10mg Placebo daily for 12 weeks

    Also known as: Inactive

06

What researchers measure

Primary outcomes

  1. Carotid Femoral Pulse Wave Velocity (cfPWV)

    cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points. Report

    Time frame: Baseline (day 0), Week 4, Week 8, Final (week 12)

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Study locations

1 of 1 sites recruiting
  • University of Missouri
    Columbia, Missouri 65211, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06506422
Lead sponsor
University of Missouri-Columbia
Responsible party
Camila Manrique, MD (Professor of Medicine, University of Missouri-Columbia) — Principal investigator
First posted
Jul 17, 2024
Start date
Aug 18, 2024
Primary completion
Oct 31, 2028 (estimated)
Completion
Feb 28, 2029 (estimated)
Last update
Feb 6, 2026

Study contacts

Camila Manrique, MD
Contact
manriquec@health.missouri.edu
(573) 882-2554
Andrea Atkins, BSN
Contact
wiesa@health.missouri.edu
(573) 884-1222

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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