Phase 3
N=137
ENAC Blockade and Arterial Stiffness
Overweight and Obesity · Insulin Resistance
Bottom Line
View on ClinicalTrials.gov: NCT03837626 ↗Enrolled (actual)
137
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Carotid Femoral Pulse Wave Velocity — 7.25; 6.80; 7.12; 6.81 m/s
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo - Cap (Drug); Amiloride Pill (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Carotid Femoral Pulse Wave Velocity |
7.25; 6.80; 7.12; 6.81 | — |
Summary
To determine whether treatment with the ENaC inhibitor, amiloride, improves endothelial function and arterial stiffness in obese insulin resistant subjects in a randomized placebo-controlled trial examining pre and postmenopausal women and age-matched men.
Eligibility Criteria
Inclusion Criteria
- 30 to 70 years of age at randomization
- Body mass index (BMI) 25.1-50 kg/m2 or waist circumference > 88 cm (> 35 in) in women and >102 cm (>40 in) in men. 3, 4
- One other characteristic of metabolic syndrome (elevated triglycerides ≥150 mg/dl; HDL cholesterol 10 mU/L (correlates with insulin resistance).
Exclusion Criteria
- History of type 1 or type 2 diabetes
- Known cardiovascular events within the last 12 months (stroke, acute coronary event, revascularization, heart failure hospitalization).
- History of uncontrolled thyroid disease, chronic liver disease (cirrhosis) or GFR 14 drinks/week for men, >7 drinks/week for women)
- Current tobacco use
- Non controlled hypertension
- Participation in regular exercise > 3 days/wk per week at a moderate or vigorous intensity
- Pregnancy or lactation in women (or women not using contraceptives)
- Women who plan to become pregnant during the duration of the trial
- Chronic use of NSAIDs
- Potassium level > 5.0 mqE/L at time of screening
- Blood pressure at screening <110/70
Data sourced from ClinicalTrials.gov (NCT03837626). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.