Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Vibegron, also known by the brand name GEMTESA, to see if it can help improve energy levels, heart health, and both physical and mental abilities in middle-aged and older adults who are obese. The trial will last for 12 weeks and will involve participants being randomly assigned to either receive Vibegron or a placebo (a harmless pill with no active ingredients) without knowing which one they are getting.

To be eligible for the trial, participants must be considered obese, which means they have a body mass index (BMI) of 30 or higher, or a BMI of 27 or higher if they have a larger waist size. However, there are some exclusions such as having major depression, uncontrolled diabetes, or certain medical conditions that could complicate the study. If someone is eligible and agrees to participate, they will be monitored throughout the study to assess how well Vibegron works for improving their overall health. This trial is currently not recruiting participants, but it aims to provide valuable insights into managing obesity and its related health issues.

Gender

ALL

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