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Vibegron for ENergy Thinking and Resilience in Aging

Not Yet RecruitingPhase 3

Sponsor: Wake Forest University Health Sciences

Conditions: Obesity

Interventions: Vibegron, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 45 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 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

Locations (1)

Winston-Salem, North Carolina, United States