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 takingOrlistatBelviqContraveSaxendaPhentermineQsymia
Rules you outMajor 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.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.