ObesityPhase 2EMPANCT06745063
Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
A Phase 2 study testing Empagliflozin in people with Obesity and Vascular Health, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Obesity, Vascular Health
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2025to 31 Dec 2029
- Phase
- Phase 2
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) 30-45 kilograms per square meter (kg/m2)
- 30-60 years of age at randomization
- Evidence of arterial stiffening (defined as Carotid femoral PWV>age-predicted) at screening visit (PMID: 20530030), or presence of Stage I hypertension or higher (PMID: 30354655), or current use of antihypertensive agents
Who cannot join
- Unable to provide consent
- Diabetes mellitus
- Uncontrolled hypertension (>180/90 millimeters of mercury) or systolic <100 millimeters of mercury at screening visit
- Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
- Diagnosis of chronic kidney disease
- Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
Show all 17Show fewer
- Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
- Use of GLP-1 analogs or SGLT2 inhibitors
- Use of hormone replacement therapy
- Use of pharmacological therapy for weight loss
- Body weight changes >10% within the past 6 months
- History of hypersensitivity to nitrates
- History of ketoacidosis
- History of recurrent UTIs or mycotic genital infections
- Use of anticoagulants
- Change in anti-hypertensive medication regimen (if in use) during the last 90 days
- Pregnancy
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
Harry S. Truman Memorial, Columbia, MO
Columbia, Missouri, 65201-5275
Jaume Padilla Parellada, PhD, (573) 814-6552, jaume.padillaparellada@va.gov
Jaume Padilla Parellada, PhD
About this study
The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.
Read the detailed description
The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10 milligrams daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45 kilograms per square meter), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.
- Conditions
- Obesity, Vascular Health
- Being tested
- Empagliflozin, Placebo
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpagliflozinDrug
12 week treatment with 10mg empagliflozin daily
PlaceboDrug
12 week treatment with 10mg placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | 12 week treatment with 10mg empagliflozin daily Receives: Drug: Empagliflozin |
| Placebo | Placebo comparator | 12 week treatment with 10mg placebo daily 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.
Measured: baseline (t0), week 4, week 8, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start30 May 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- placebo-controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- University of Missouri-Columbia
- Responsible party
- Sponsor
- Investigators
- Jaume Padilla Parellada, PhD, Principal investigator, Harry S. Truman Memorial, Columbia, MO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745063
- Sponsor's protocol ID
- CARB-015-24S
- Other IDs
- 1I01CX002859-01, 2107866
- Acronym
- EMPA
- Status last verified
- Oct 2026
- First submitted
- 17 Dec 2024
- Last updated
- 22 Oct 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 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Destiffening Effects of SGLT2 Inhibition in Veterans With Obesity
- ClinicalTrials.gov ID
- NCT06745063
- Acronym / sponsor ID
- EMPA / CARB-015-24S
- Conditions
- Obesity, Vascular Health
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- University of Missouri-Columbia
- Study start
- 30 May 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 20 Dec 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.
The study will assign participants to take either the medication, empagliflozin or a placebo for 12 weeks. The goal of the study is to determine the effects of empagliflozin on arterial health in Veterans with obesity.
Detailed description
The investigators will employ a double-blinded randomized placebo-controlled trial to determine the effects of 12 weeks of SGLT2 inhibition with empagliflozin (10 milligrams daily), or matching placebo, on arterial stiffness in Veterans with obesity. Fifty Veterans with obesity (BMI 30-45 kilograms per square meter), 30-60 years of age, will be recruited from the Harry S. Truman Memorial VA Hospital in Columbia, Missouri.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin12 week treatment with 10mg empagliflozin daily |
| Placebo | Placebo comparator | Drug: Placebo12 week treatment with 10mg placebo daily |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) 30-45 kilograms per square meter (kg/m2)
- 30-60 years of age at randomization
- Evidence of arterial stiffening (defined as Carotid femoral PWV>age-predicted) at screening visit (PMID: 20530030), or presence of Stage I hypertension or higher (PMID: 30354655), or current use of antihypertensive agents
Key exclusion criteria (17 listed)
- Unable to provide consent
- Diabetes mellitus
- Uncontrolled hypertension (>180/90 millimeters of mercury) or systolic <100 millimeters of mercury at screening visit
- Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
- Diagnosis of chronic kidney disease
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 |
|---|---|---|
| Empagliflozin12 week treatment with 10mg empagliflozin daily | Drug | Empagliflozin |
| Placebo12 week treatment with 10mg placebo daily | Drug | Placebo |
Primary outcome
Carotid-femoral Pulse Wave Velocity (cfPWV)
Time frame: baseline (t0), week 4, week 8, 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.
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 22 Oct 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.
Jaume Padilla Parellada, PhD principal investigator
Harry S. Truman Memorial, Columbia, MO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Empagliflozin in people with Obesity and Vascular Health, run by VA Office of Research and Development 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 3 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 22 Oct 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 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.
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 Jaume Padilla Parellada, PhD ((573) 814-6552, jaume.padillaparellada@va.gov), 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 (t0), week 4, week 8, 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 22 Oct 2026.