Vibegron for energy, thinking, and resilience in obesity in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3, randomized, double-blind, placebo-controlled trial, researchers will compare daily Vibegron (75 mg) to placebo over 12 weeks in 40 middle-aged and older adults with obesity. Participants will be screened by phone and then in person, be randomly assigned to treatment or placebo, and complete baseline and follow-up assessments of metabolic, cardiometabolic, physical, and cognitive outcomes along with safety checks. The study aims to understand if activating β3 adrenergic receptors to stimulate brown adipose tissue can mitigate aging- and obesity-related declines in physiological function. Results will inform whether Vibegron could improve energy handling and multisystem health in this population.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Tina E Brinkley, PhD — Wake Forest University Health Sciences
• Study coordinator: Tina E. Brinkley, PhD
• Email: tbrinkle@wakehealth.edu
• Phone: 336-713-8534

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.