Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity
Wake Forest University Health Sciences
Summary
This 12-week randomized, double-blind, placebo-controlled trial will test the hypothesis that Vibegron (brand name GEMTESA) can improve energy metabolism, cardiometabolic risk factors, and physical and cognitive function in middle-aged and older adults with obesity.
Description
Aging is characterized by the gradual loss of physiological integrity, and this process may be accelerated in the presence of obesity, increasing susceptibility to disease, frailty, and death. Although the shared molecular pathways involved have not been fully elucidated, adipose tissue dysfunction is likely a key contributor to multisystem functional decline in aging and obesity. Despite growing evidence that β3 adrenergic receptor (β3AR) mediated activation of brown adipose tissue (BAT) may alter pathophysiological pathways implicated in various aging-related diseases including metabolic, ca…
Eligibility
- Age range
- 45–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference \>102 cm for men and \>88 cm for women) Exclusion Criteria: * Body weight ≥450 pounds * Major depression * Evidence of cognitive impairment * Uncontrolled diabetes (hemoglobin A1c \>7%) * Weight gain or loss of ≥5% over the past 6 months * Prior weight loss procedure (e.g., gastric bypass, sleeve gastrectomy, gastric banding) * Regular use of the following: weight loss medications (e.g., Orlistat, Belviq, Contrave, Saxenda, Phentermine, Qsymia); medications or dietary supplements known to alter energy met…
Interventions
- DrugVibegron
A drug in a class of medications called beta-3 adrenergic agonists; approved for use with Overactive Bladder; 75mg tablets will be used in this study
- DrugPlacebo
Tablets made of inert substance that looks like the vibegron tablets but has no therapeutic value
Location
- Wake Forest University Health SciencesWinston-Salem, North Carolina