NCT06987383RecruitingPhase 3
Vibegron for ENergy Thinking and Resilience in Aging
Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 15 May 2025
- Start date
- 27 Oct 2026
- Primary completion date
- Jul 2028
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Obesity
- NCT number
- NCT06987383
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 40
- From 27 Oct 2026 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Drug/substance abuse or excessive alcohol use within the past 6 months
Other illness
- Evidence of cognitive impairment
- 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
Lab values
- Uncontrolled diabetes (hemoglobin A1c \>7%)
Other
- Body weight ≥450 pounds
- Major depression
- Weight gain or loss of ≥5% over the past 6 months
- Benign prostate hyperplasia
- Contraindication to Vibegron or any of its components
- Current participation in another intervention or research study that prohibits co-enrollment
Who the study is looking for
- Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference \>102 cm for men and \>88 cm for women)
Age in the registry: 45 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.