Vibegron for Energy and Resilience in Aging with Obesity

This 12-week study is looking at how Vibegron (brand name GEMTESA) affects energy levels, heart health, and physical and mental function in middle-aged and older adults with obesity. Vibegron is a drug already approved for overactive bladder. We want to see if it can improve how your body uses energy. You might be able to join if you are between 45 and 75 years old and have obesity (a Body Mass Index, or BMI, of 30 or higher, or a BMI of 27 or higher with a large waist circumference). This study is currently recruiting 40 participants, but its overall status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study involving 40 participants. You would be randomly assigned to receive either Vibegron or a placebo (an inactive pill that looks like Vibegron).
What's involved
You would take the study drug by mouth once daily for 12 weeks. There will be an initial telephone screening, followed by an in-person screening at Atrium Health Wake Forest Baptist.
Compensation
Not stated in the trial record.
Follow-up
Your Resting Metabolic Rate will be measured at the beginning of the study (Baseline) and again at Week 12.

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NCT06987383

Vibegron for ENergy Thinking and Resilience in Aging

Not Yet Recruiting
PHASE3Ages 45–75InterventionalTreatment
Wake Forest University Health Sciences
~40 participants
Updated 2026-09-03 on ClinicalTrials.gov
What's tested:VibegronPlacebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Resting Metabolic Rate
Measured over Baseline
+1 more outcome measured
Obesity
1 sites across 1 states
North Carolina1
  • Tina E Brinkley, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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Do you actually qualify for this trial?

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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
  • Resting Metabolic RateBaseline

    Resting metabolic rate (RMR) will be measured by indirect calorimetry using a computerized metabolic cart that provides valid and reliable measurement of oxygen consumption and carbon dioxide production - RMR can be estimated using formulas such as the Mifflin-St Jeor equation: Males: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) + 5 Females: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) - 161

  • Resting Metabolic RateWeek 12

    Resting metabolic rate (RMR) will be measured by indirect calorimetry using a computerized metabolic cart that provides valid and reliable measurement of oxygen consumption and carbon dioxide production - RMR can be estimated using formulas such as the Mifflin-St Jeor equation: Males: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) + 5 Females: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) - 161