Vibegron for ENergy Thinking and Resilience in Aging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vibegron, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 45 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity
Overview
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.
Detailed description
Aging is characterized by the gradual loss of physiological integrity, and this process may be accelerated in the presence of obesity, increasing susceptibility to disease, frailty, and death. Although the shared molecular pathways involved have not been fully elucidated, adipose tissue dysfunction is likely a key contributor to multisystem functional decline in aging and obesity. Despite growing evidence that β3 adrenergic receptor (β3AR) mediated activation of brown adipose tissue (BAT) may alter pathophysiological pathways implicated in various aging-related diseases including metabolic, cardiovascular, and neurodegenerative diseases, BAT has been largely ignored in aging research. This study will randomize 40 middle-aged and older adults (45-75 yrs) with obesity to the β3AR agonist Vibegron (75 mg/day) or placebo for 12 weeks to compare their effects on various bioenergetic, cardiometabolic, physical function, and cognitive outcomes. Potential study candidates will be screened by telephone to determine basic interest and eligibility. Individuals who pass this initial screening will then undergo an in-person screening at Atrium Health Wake Forest Baptist. Enrolled participants will be randomized 1:1 to Vibegron or placebo and will be instructed to take the study drug by mouth once daily for 12 weeks. Study outcomes will be assessed at the baseline and follow-up visits and at one safety/compliance visit. Participants will self-report demographic, behavioral, and medical information using questionnaires. They will also complete functional tests to assess muscle strength/power and mobility, DXA and CT scans to assess body composition and body fat distribution, and remote monitoring to assess core body temperature. In addition, participants will have their blood drawn for the assessment of glucose/insulin and lipid indices, for screening and safety purposes, and for storage of plasma/serum samples. Blood samples will also be used to assess mitochondrial bioenergetics in peripheral blood mononuclear cells and thermogenic and adipokine protein expression in adipose tissue-derived small extracellular vesicles. Safety will be assessed based on treatment-related adverse events and measurement of blood chemistries and vitals. To assess medication adherence, participants will be instructed to keep a daily dosing diary and to bring the log, along with empty pill bottles, to the safety/compliance visit for review by the study team.
Interventions
- Drug Vibegron
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 - Drug Placebo
Tablets made of inert substance that looks like the vibegron tablets but has no therapeutic value
Primary outcome measures
- Resting Metabolic Rate [Time frame: Baseline]
- Resting Metabolic Rate [Time frame: Week 12]
Secondary outcome measures (2)
- Glucose Tolerance Level [Time frame: Baseline and Week 12]
- Expanded Short Physical Performance Battery (eSPPB) [Time frame: Baseline and Week 12]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT06987383 · Brinkley.Vibegron · R21AG091075