Recruiting
Phase 2

Empagliflozin

Sponsor:

VA Office of Research and Development

Code:

NCT06745063

Conditions

Obesity

Vascular Health

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

Interventions

Empagliflozin

Placebo

Study Details

Brief 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.

Conditions

Obesity

Vascular Health

Study ID

NCT06745063

Start date

May 30, 2025

Status verified date

Nov, 2025

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Body mass index (BMI) 30-45 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)

Exclusion Criteria:

  • Unable to provide consent
  • Diabetes mellitus
  • Uncontrolled hypertension (>180/90mmHg) or systolic <100mmHg 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)
  • 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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empagliflozin

12 week treatment with 10mg empagliflozin daily

placebo comparator: Placebo

12 week treatment with 10mg placebo daily

Interventions

Empagliflozin

12 week treatment with 10mg empagliflozin daily

Placebo

12 week treatment with 10mg placebo daily

Primary outcome measure

  • Carotid-femoral Pulse Wave Velocity (cfPWV) [ Time Frame: baseline (t0), week 4, week 8, week 12 ]

Central Contacts and Locations

Central contacts

Jaume Padilla Parellada, PhD

(573) 814-6552jaume.padillaparellada@va.gov

Katherine M Burr

(573) 814-6550Katherine.Burr@va.gov

Locations

Harry S. Truman Memorial, Columbia, MO

Recruiting

Columbia, Missouri, United States, 65201-5275

Contacts

Jaume Padilla Parellada, PhD

573-814-6552jaume.padillaparellada@va.gov

Principal Investigator:

Jaume Padilla Parellada, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-14.