Vibegron for ENergy Thinking and Resilience in Aging

NCT06987383 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: Brinkley.VibegronR21AG091075
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Vibegron; aging; metabolism; physical function; cognitive function

Outcome Measures

Primary Outcomes (2)

• Resting Metabolic Rate

  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

  Baseline

• Resting Metabolic Rate

  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

  Week 12

Secondary Outcomes (2)

• Glucose Tolerance Level

  Baseline and Week 12

• Expanded Short Physical Performance Battery (eSPPB)

  Baseline and Week 12

Other Outcomes (5)

• Core body temperature

  Baseline and Week 12

• Lipid levels

  Baseline, Week 4, and Week 12

• Depressive Symptoms: 15-item Geriatric Depression Scale (GDS-15)

  Baseline and Week 12

Study Arms (2)

Vibegron

EXPERIMENTAL

Participants in this arm will take 75mg/day Vibegron for 12 weeks.

Drug: Vibegron

Placebo

PLACEBO COMPARATOR

Participants in this arm will take placebo daily for 12 weeks.

Drug: Placebo

Interventions

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

Also known as: Gemtesa

Vibegron

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference \>102 cm for men and \>88 cm for women)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tina E Brinkley, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tina E. Brinkley, PhD

CONTACT

336-713-8534; tbrinkle@wakehealth.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacy will provide Vibegron tablets and create matching placebo. Participants will be randomized 1:1 to either arm
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)