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Not Yet Recruiting NCT06987383

Vibegron for ENergy Thinking and Resilience in Aging

Conditions: Obesity

Sex: All
Ages: 45 Years – 75 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 40
Sponsor: Wake Forest University Health Sciences

Location: Wake Forest University Health Sciences Winston-Salem North Carolina

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06987383). StuddyBuddy aggregates publicly available trial information.