Status:
NOT_YET_RECRUITING
Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Obesity
Eligibility:
All Genders
45-75 years
Phase:
PHASE3
Brief 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 an...
Detailed 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. Althoug...
Eligibility Criteria
Inclusion
- Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference \>102 cm for men and \>88 cm for women)
Exclusion
- 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 metabolism; adrenergic agonists or beta blockers
- Symptoms of urinary retention, incontinence, urgency, and frequency or current use of an antimuscarinic medication to treat overactive bladder
- Benign prostate hyperplasia
- Significant medical illness or organ failure, such as uncontrolled hypertension, advanced kidney disease, liver disease, thyroid disease, or active neoplastic disease
- Diagnosis of a neurodegenerative illness (e.g., mild cognitive impairment, dementia, Parkinson's disease, Multiple Sclerosis)
- History of a clinically significant stroke
- Cardiac arrhythmia or an abnormal Electrocardiogram
- Drug/substance abuse or excessive alcohol use within the past 6 months
- Contraindication to Vibegron or any of its components
- Current participation in another intervention or research study that prohibits co-enrollment
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06987383
Start Date
August 1 2026
End Date
July 1 2028
Last Update
July 28 2025
Active Locations (1)
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1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157