Vibegron for Improving Energy in Obese Adults

Vibegron for ENergy Thinking and Resilience in Aging

Recruiting Phase 3 Interventional Study
Obesity
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
45 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Wake Forest University Health Sciences · Other
Who this trial is looking for

This trial is looking for middle-aged and older adults who are obese. Participants will take a medication called Vibegron for 12 weeks to see if it helps increase their energy and improve their overall health.

Are You a Good Fit for This Trial?
Must not be taking OrlistatBelviqContraveSaxendaPhentermineQsymia
Rules you out Major depressionCognitive impairmentUncontrolled diabetesWeight changePrior weight loss procedureUrinary retention issuesSignificant medical illness

You may be able to join if

  • I am obese with a BMI of 30 or higher
  • I am obese with a BMI of 27 or higher and my waist is over 102 cm for men or over 88 cm for women

You may not be able to join if

  • My body weight is 450 pounds or more
  • I have major depression
  • I have signs of cognitive impairment
  • My diabetes is not under control
  • I have gained or lost 5% of my weight in the last 6 months
  • I have had a weight loss procedure before
  • I have symptoms of urinary problems or use medication for an overactive bladder
  • I have a significant medical illness or organ failure

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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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…
Contacts

Tina E. Brinkley, PhD

336-713-8534

tbrinkle@wakehealth.edu

CONTACT