Trial · NCT06987383
Vibegron for ENergy Thinking and Resilience in Aging
NCT06987383, Phase 3, Recruiting, Wake Forest University Health Sciences
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vibegron for ENergy Thinking and Resilience in Aging. Trials, record NCT06987383. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06987383
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vibegron for ENergy Thinking and Resilience in Aging
- NCT number
- NCT06987383
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Wake Forest University Health Sciences
- Conditions
- Obesity
- Interventions
- Vibegron, Placebo
- First posted
- 2025-05-23
- Last updated
- 2026-10-28
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Resting Metabolic Rate | 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 |
| Primary | Resting Metabolic Rate | 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 |
| Secondary | Glucose Tolerance Level | Baseline and Week 12 | 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. |
| Secondary | Expanded Short Physical Performance Battery (eSPPB) | Baseline and Week 12 | 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. |
| Other | Core body temperature | Baseline and Week 12 | Core body temperature will be measured continuously using a temperature monitoring patch worn on the chest. |
| Other | Lipid levels | Baseline, Week 4, and Week 12 | Plasma levels of total cholesterol, VLDL cholesterol, HDL cholesterol, and triglycerides will be measured in fasted blood samples. |
| Other | Depressive Symptoms: 15-item Geriatric Depression Scale (GDS-15) | Baseline and Week 12 | Questionnaire used to measure depressive symptoms in the elderly; ranges from 0-15 with higher scores indicating greater severity of depression; score of 0-4 is within normal range; score of 5-8 mild depression; score of 9-11 moderate depression; score of 12-15 severe depression |
| Other | Quality of Life: Medical Outcomes Study Short Form 36 (SF-36) | Baseline and Week 12 | Quality of life questionnaire with a score that ranges from 0 to 100 with higher scores indicating better quality of life. |
| Other | Compliance Rate | Baseline, Week 4, and Week 12 | Compliance will be defined based on the number of daily doses taken relative to the total number of doses prescribed. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R21AG091075 | Vibegron: A Novel Treatment for Multisystem Functional Decline in Aging and Obesity | Brinkley, Tina E | WAKE FOREST UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE ON AGING | 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06987383
GET https://conductscience.org/api/trials/v1/NCT06987383/registered