Vibegron for ENergy Thinking and Resilience in Aging

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06987383

Run by

Wake Forest University Health Sciences

People needed

40

Starts

2026-09-01

Expected to finish

2028-07-01

Last updated by the study team

2026-08-04

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference >102 cm for men and >88 cm for women)

You may not qualify if…

• 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

Where it is running

• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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