Clinical trial

Vibegron for ENergy Thinking and Resilience in Aging

Opening soon · Phase 3 · 1 countries · Registry ID NCT06987383

Opening soonPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age45 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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

Treatments and study arms

Vibegron

Drug

A drug in a class of medications called beta-3 adrenergic agonists; approved for use with Overactive Bladder; 75mg tablets will be used in this study

Placebo

Drug

Tablets made of inert substance that looks like the vibegron tablets but has no therapeutic value

Primary outcomes

Resting Metabolic RateBaseline

Resting metabolic rate (RMR) will be measured by indirect calorimetry using a computerized metabolic cart that provides valid and reliable measurement of oxygen consumption and carbon dioxide production - RMR can be estimated using formulas such as the Mifflin-St Jeor equation: Males: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) + 5 Females: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) - 161

Resting Metabolic RateWeek 12

Resting metabolic rate (RMR) will be measured by indirect calorimetry using a computerized metabolic cart that provides valid and reliable measurement of oxygen consumption and carbon dioxide production - RMR can be estimated using formulas such as the Mifflin-St Jeor equation: Males: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) + 5 Females: RMR = 10 \* weight (kg) + 6.25 \* height (cm) - 5 \* age (years) - 161

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Wake Forest University Health Sciences🇺🇸 Winston-Salem, North Carolina, United States
Tina E Brinkley, PhDContact
Tina E Brinkley, PhDPrincipal Investigator