[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06987383":3,"trial-entities:NCT06987383":111,"trial-summary:NCT06987383":114},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":44,"secondary_outcomes":51,"sex":59,"minimum_age":60,"maximum_age":61,"healthy_volunteers":62,"eligibility_criteria":63,"std_ages":84,"locations":87,"central_contacts":103,"overall_officials":107,"references":109,"see_also_links":110},"NCT06987383","Brinkley.Vibegron","Vibegron for ENergy Thinking and Resilience in Aging","Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity","NOT_YET_RECRUITING","2028-07","2026-09","2026-09-03","2026-10","Wake Forest University Health Sciences","OTHER",true,"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.","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\u002Fday) 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\u002Fcompliance visit. Participants will self-report demographic, behavioral, and medical information using questionnaires. They will also complete functional tests to assess muscle strength\u002Fpower 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\u002Finsulin and lipid indices, for screening and safety purposes, and for storage of plasma\u002Fserum 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\u002Fcompliance visit for review by the study team.",[19],"Obesity",[21,22,23,24,25],"Vibegron","aging","metabolism","physical function","cognitive function","INTERVENTIONAL","TREATMENT",[29],"PHASE3",{"count":31,"type":32},40,"ESTIMATED",[34,40],{"type":35,"name":21,"description":36,"armGroupLabels":37,"otherNames":38},"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",[21],[39],"Gemtesa",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Placebo","Tablets made of inert substance that looks like the vibegron tablets but has no therapeutic value",[41],[45,49],{"measure":46,"description":47,"timeFrame":48},"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:\n\nMales: 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",{"measure":46,"description":47,"timeFrame":50},"Week 12",[52,56],{"measure":53,"description":54,"timeFrame":55},"Glucose Tolerance Level","Glucose tolerance will be assessed using a standard 75-g oral glucose load to measure changes in glucose and insulin levels. Glucose tolerance will be defined as the 2-hour glucose level - a normal two-hour post-glucose level is below 140 mg\u002FdL (7.8 mmol\u002FL). Levels between 140 and 199 mg\u002FdL (7.8 and 11 mmol\u002FL) indicate impaired glucose tolerance (also called prediabetes), while levels of 200 mg\u002FdL (11.1 mmol\u002FL) or higher suggest diabetes.","Baseline and Week 12",{"measure":57,"description":58,"timeFrame":55},"Expanded Short Physical Performance Battery (eSPPB)","Lower extremity function will be assessed using the eSPPB which measures balance, gait speed, and leg strength - Each component is scored separately, and then the scores are summed to give a total score ranging from 0 (worst) to 12 (best) - The total score is calculated by summing the scores from the three subtests.\n\nA higher total score indicates better lower extremity function, while a lower score indicates more functional limitations.","ALL","45 Years","75 Years",false,{"inclusion":64,"exclusion":66,"raw_text":83},[65],"Obese (BMI ≥30 kg\u002Fm2 or BMI ≥27 kg\u002Fm2 with a waist circumference \\>102 cm for men and \\>88 cm for women)",[67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82],"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\u002Fsubstance 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","Inclusion Criteria:\n\n* Obese (BMI ≥30 kg\u002Fm2 or BMI ≥27 kg\u002Fm2 with a waist circumference \\>102 cm for men and \\>88 cm for women)\n\nExclusion Criteria:\n\n* Body weight ≥450 pounds\n* Major depression\n* Evidence of cognitive impairment\n* Uncontrolled diabetes (hemoglobin A1c \\>7%)\n* Weight gain or loss of ≥5% over the past 6 months\n* Prior weight loss procedure (e.g., gastric bypass, sleeve gastrectomy, gastric banding)\n* 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\n* Symptoms of urinary retention, incontinence, urgency, and frequency or current use of an antimuscarinic medication to treat overactive bladder\n* Benign prostate hyperplasia\n* Significant medical illness or organ failure, such as uncontrolled hypertension, advanced kidney disease, liver disease, thyroid disease, or active neoplastic disease\n* Diagnosis of a neurodegenerative illness (e.g., mild cognitive impairment, dementia, Parkinson's disease, Multiple Sclerosis)\n* History of a clinically significant stroke\n* Cardiac arrhythmia or an abnormal Electrocardiogram\n* Drug\u002Fsubstance abuse or excessive alcohol use within the past 6 months\n* Contraindication to Vibegron or any of its components\n* Current participation in another intervention or research study that prohibits co-enrollment",[85,86],"ADULT","OLDER_ADULT",[88],{"facility":13,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":100},"Winston-Salem","North Carolina","27157","United States",[94,98],{"name":95,"role":96,"phone":97},"Tina E Brinkley, PhD","CONTACT","336-713-8534",{"name":95,"role":99},"PRINCIPAL_INVESTIGATOR",{"lat":101,"lon":102},36.09986,-80.24422,[104],{"name":105,"role":96,"phone":97,"email":106},"Tina E. Brinkley, PhD","tbrinkle@wakehealth.edu",[108],{"name":95,"affiliation":13,"role":99},[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[19],[],{"nct_id":4,"found":15,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is a randomized, double-blind, placebo-controlled study involving 40 participants. You would be randomly assigned to receive either Vibegron or a placebo (an inactive pill that looks like Vibegron).","completed","Vibegron for Energy and Resilience in Aging with Obesity","This 12-week study is looking at how Vibegron (brand name GEMTESA) affects energy levels, heart health, and physical and mental function in middle-aged and older adults with obesity. Vibegron is a drug already approved for overactive bladder. We want to see if it can improve how your body uses energy. You might be able to join if you are between 45 and 75 years old and have obesity (a Body Mass Index, or BMI, of 30 or higher, or a BMI of 27 or higher with a large waist circumference). This study is currently recruiting 40 participants, but its overall status is unclear.","Your Resting Metabolic Rate will be measured at the beginning of the study (Baseline) and again at Week 12.",103,"You would take the study drug by mouth once daily for 12 weeks. There will be an initial telephone screening, followed by an in-person screening at Atrium Health Wake Forest Baptist.","Not stated in the trial record.",[21],"v2"]