ObesityPhase 3VENTURANCT06987383
Vibegron for ENergy Thinking and Resilience in Aging
A Phase 3 study testing Vibegron in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Obesity
- What is being tested?
- Vibegron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2026to Jul 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference >102 cm for men and >88 cm for women)
Who cannot join
- 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)
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Tina E Brinkley, PhD, 336-713-8534
Charlotte Crotts, 336-713-8503
About this study
Official title: Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- Vibegron, Placebo
- Keywords
- Vibegron, aging, metabolism, physical function, cognitive function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VibegronDrug
Also called Gemtesa
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
PlaceboDrug
Tablets made of inert substance that looks like the vibegron tablets but has no therapeutic value
| Study group | Role | What they receive |
|---|---|---|
| Vibegron | Experimental | Participants in this arm will take 75mg/day Vibegron for 12 weeks. Receives: Drug: Vibegron |
| Placebo | Placebo comparator | Participants in this arm will take placebo daily for 12 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Week 12
Secondary outcomes (2)
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/dL (7.8 mmol/L). Levels between 140 and 199 mg/dL (7.8 and 11 mmol/L) indicate impaired glucose tolerance (also called prediabetes), while levels of 200 mg/dL (11.1 mmol/L) or higher suggest diabetes.
Measured: Baseline and Week 12
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.
A higher total score indicates better lower extremity function, while a lower score indicates more functional limitations.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start27 Oct 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Tina E Brinkley, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987383
- Sponsor's protocol ID
- Brinkley.Vibegron
- Other IDs
- R21AG091075
- Acronym
- VENTURA
- Status last verified
- Oct 2026
- First submitted
- 15 May 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibegron - A Novel Treatment for Multisystem Functional Decline in Aging and Obesity
- ClinicalTrials.gov ID
- NCT06987383
- Acronym / sponsor ID
- VENTURA / Brinkley.Vibegron
- Conditions
- Obesity
- Keywords
- Vibegron, aging, metabolism, physical function, cognitive function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 27 Oct 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibegron | Experimental | Drug: VibegronParticipants in this arm will take 75mg/day Vibegron for 12 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in this arm will take placebo daily for 12 weeks. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Obese (BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with a waist circumference >102 cm for men and >88 cm for women)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VibegronAlso: GemtesaA 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 | Vibegron |
| PlaceboTablets made of inert substance that looks like the vibegron tablets but has no therapeutic value | Drug | Placebo |
Primary outcome
Resting Metabolic Rate
Time frame: Baseline
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 Rate
Time frame: Week 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
2 secondary outcomes
Glucose Tolerance Level
Time frame: Baseline and Week 12
Expanded Short Physical Performance Battery (eSPPB)
Time frame: Baseline and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina E Brinkley, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vibegron in people with Obesity, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tina E. Brinkley, PhD (336-713-8534, tbrinkle@wakehealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting Metabolic Rate (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.