NCT06987383 Vibegron for ENergy Thinking and Resilience in Aging
| NCT ID | NCT06987383 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-10-27 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 40 participants in total. It began in 2026-10-27 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 ≥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
Contact & Investigator
Tina E Brinkley, PhD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT06987383 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06987383 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 40 participants.
Is NCT06987383 currently recruiting?
Yes, NCT06987383 is actively recruiting participants. Contact the research team at tbrinkle@wakehealth.edu for enrollment information.
Where is the NCT06987383 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT06987383 clinical trial?
NCT06987383 is sponsored by Wake Forest University Health Sciences. The principal investigator is Tina E Brinkley, PhD at Wake Forest University Health Sciences. The trial plans to enroll 40 participants.
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