NCT06745063

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 obesity

Timeline
45mo left

Started May 2025

Longer than P75 for phase_2 obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress20%
May 2025Dec 2029

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

May 30, 2025

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

3.6 years

First QC Date

December 17, 2024

Last Update Submit

November 13, 2025

Conditions

ObesityVascular Health

Outcome Measures

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.

    baseline (t0), week 4, week 8, week 12

Study Arms (2)

Empagliflozin

EXPERIMENTAL

12 week treatment with 10mg empagliflozin daily

Drug: Empagliflozin

Placebo

PLACEBO COMPARATOR

12 week treatment with 10mg placebo daily

Drug: Placebo

Interventions

EmpagliflozinDRUG

12 week treatment with 10mg empagliflozin daily

Empagliflozin
PlaceboDRUG

12 week treatment with 10mg placebo daily

Placebo

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index (BMI) 30-45 kg/m2
  • years of age at randomization
  • Evidence of arterial stiffening (defined as Carotid femoral PWV\>age-predicted) at screening visit (PMID: 20530030)

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harry S. Truman Memorial, Columbia, MO

Columbia, Missouri, 65201-5275, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jaume Padilla Parellada, PhD

    Harry S. Truman Memorial, Columbia, MO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jaume Padilla Parellada, PhD

CONTACT

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

Katherine M Burr

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
double-blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: placebo-controlled trial
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

May 30, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)