AgingPhase 2/3ERASE-AgingNCT06506422
Empagliflozin Reversal of Arterial StiffnEss in Aging
A Phase 2/3 study testing Empagliflozin 10 MG in people with Aging and Arterial Stiffness, run by University of Missouri-Columbia at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Arterial Stiffness
- What is being tested?
- Empagliflozin 10 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2024to 28 Feb 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Missouri
Columbia, Missouri, 65211
Andrea Atkins, BSN, 573-884-1222, wiesa@health.missouri.edu
About this study
Official title: SGLT2 Inhibition as a Therapeutic Strategy to Reverse Arterial Stiffening in Aging
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.
- Conditions
- Aging, Arterial Stiffness
- Being tested
- Empagliflozin 10 MG, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Active
10mg Empagliflozin daily for 12 weeks
PlaceboDrug
Also called Inactive
10mg Placebo daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | 10mg Empagliflozin daily for 12 weeks Receives: Drug: Empagliflozin 10 MG |
| Placebo | Placebo comparator | 10mg Placebo daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (day 0), Week 4, Week 8, Final (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start18 Aug 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double-blinded randomized placebo control trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camila Manrique, MD, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506422
- Sponsor's protocol ID
- 2097602
- Acronym
- ERASE-Aging
- Status last verified
- Feb 2026
- First submitted
- 11 Jul 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibition as a Therapeutic Strategy to Reverse Arterial Stiffening in Aging
- ClinicalTrials.gov ID
- NCT06506422
- Acronym / sponsor ID
- ERASE-Aging / 2097602
- Conditions
- Aging, Arterial Stiffness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 18 Aug 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 17 Jul 2024 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- double-blinded randomized placebo control trial
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin 10 MG10mg Empagliflozin daily for 12 weeks |
| Placebo | Placebo comparator | Drug: Placebo10mg Placebo daily for 12 weeks |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
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 |
|---|---|---|
| Empagliflozin 10 MGAlso: Active10mg Empagliflozin daily for 12 weeks | Drug | Empagliflozin |
| PlaceboAlso: Inactive10mg Placebo daily for 12 weeks | Drug | Placebo |
Primary outcome
Carotid Femoral Pulse Wave Velocity (cfPWV)
Time frame: Baseline (day 0), Week 4, Week 8, Final (week 12)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Empagliflozin 10 MG in people with Aging and Arterial Stiffness, run by University of Missouri-Columbia 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 17 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: looking for participants now, as of the sponsor's last update on 6 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camila Manrique, MD ((573) 882-2554, manriquec@health.missouri.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carotid Femoral Pulse Wave Velocity (cfPWV) (time frame: Baseline (day 0), Week 4, Week 8, Final (week 12)). 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 6 Feb 2026.