Recruiting
Phase 3

Vibegron

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06987383

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Vibegron

Placebo

Study Details

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 and cognitive function in middle-aged and older adults with obesity.

Conditions

Obesity

Study ID

NCT06987383

Start date

Oct 27, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vibegron

Participants in this arm will take 75mg/day Vibegron for 12 weeks.

placebo comparator: Placebo

Participants in this arm will take placebo daily for 12 weeks.

Interventions

Vibegron

A drug in a class of medications called beta-3 adrenergic agonists; approved for use with Overactive Bladder; 75mg tablets will be used in this study

Placebo

Tablets made of inert substance that looks like the vibegron tablets but has no therapeutic value

Primary outcome measure

  • Resting Metabolic Rate [ Time Frame: Baseline ]
  • Resting Metabolic Rate [ Time Frame: Week 12 ]

Central Contacts and Locations

Central contacts

Tina E. Brinkley, PhD

336-713-8534tbrinkle@wakehealth.edu

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Tina E Brinkley, PhD

336-713-8534

Charlotte Crotts

336-713-8503

Principal Investigator:

Tina E Brinkley, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • Vibegron
  • aging
  • metabolism
  • physical function
  • cognitive function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.