ObesityPhase 4NCT07057310
Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women
A Phase 4 study testing semaglutide or tirzepatide and Lifestyle modification intervention in people with Obesity and Menopause, run by Mayo Clinic at 1 site in United States.
Trial summary
In postmenopausal women, obesity increases the risk of physical function decline, premature aging, and vascular dysfunction. Semaglutide and tirzepatide are potent obesity medications. Read more about this study
- Who is it for?
- Ages 46 to 60 years, women only
- What is being tested?
- semaglutide or tirzepatide and Lifestyle modification intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2025to 31 Mar 2027
- Phase
- Phase 4
- 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 46 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Postmenopausal women (with menopause defined as the cessation of menstrual periods for at least 12 months or history of bilateral oophorecomy)
- Age 46-60 years old
- BMI ≥ 30 kg/m2.
Who cannot join
- Past or current use of menopausal hormone therapy
- Early or premature menopause
- History of chemically induced menopause
- Impaired renal function (GFR ≤29)
- Thyroid-stimulating hormone ≥7 with low free T4
- Diabetes
Show all 17Show fewer
- Cardiovascular disease
- Elevated blood pressure (>170/>95)
- Uncontrolled co-morbidities including inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, or psychiatric disease
- >5% change in weight during the 3 months prior to screening
- Other anti-obesity medication use within the past 3 months
- History of bariatric surgery
- History of malignant neoplasms within the past 5 years prior to screening
- Current use of supplements known to affect weight
- Personal or family history of medullary thyroid cancer.
- Wheelchair bound
- Vision loss
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
In postmenopausal women, obesity increases the risk of physical function decline, premature aging, and vascular dysfunction. Semaglutide and tirzepatide are potent obesity medications. The goal is to determine the effect of weight loss induced by the new generation of GLP-1 receptor agonists on physical function, aging biomarkers, and vascular function in postmenopausal women with obesity.
- Being tested
- semaglutide or tirzepatide, Lifestyle modification intervention
- Keywords
- obesity, vascular function, aging, postmenopause, women
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutide or tirzepatideDrug
Semaglutide and tirzepatide will be dosed as per prescription labels
Lifestyle modification interventionBehavioural
All participants will be recommended the following: 1) low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day; 2) physical activity: a goal of 10,000 steps or more per day; 3) exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week; 4) limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Weight loss medication and standard lifestyle intervention | Experimental | Subjects will receive tirzepatide or semaglutide in combination with a standard lifestyle intervention. Receives: Drug: semaglutide or tirzepatide; Behavioral: Lifestyle modification intervention |
| Standard lifestyle intervention only | Active comparator | Subjects will receive standard of care lifestyle intervention only. Receives: Behavioral: Lifestyle modification intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Function Measure: Short Physical Performance Battery (SPPB) score.
The SPPB is a standardized test that evaluates lower extremity function using three components: balance tests (standing in various positions), gait speed (walking a short distance), and chair stand (repeated standing from a seated position). Each component is scored from 0 to 4; the total score ranges from 0 to 12. Higher scores represent better physical function.
Measured: 24 weeks
Physical Function Measure: Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) performed on the Rehabilitation Artificial Physical Intelligence Database (RAPID) foot pressure mat
The mCTSIB assesses balance under four sensory conditions: eyes open/closed on firm and foam surfaces. Testing is performed while standing on the RAPID foot pressure mat, which captures center of pressure and postural sway data. The primary measure is average sway area of the four sensory conditions. The sway area is the area which is required to correct equilibrium, representing the total area covered by postural sway, measured in square centimeters (cm²).
Measured: 24 weeks
Physical Function Measure: Standing Chest Throw Test with a 2-kg Weighted Ball using Motion Sensor Technology (MST)
This test evaluates upper body muscular power. Participants perform a two-handed chest throw of a 2-kg medicine ball from a standing position. The MST is used to record throw distance, velocity, and related performance metrics. The primary measure is Peak Power Score (W).
Measured: 24 weeks
Physical Function Measure: Chair-to-Stand Tests using Motion Sensor Technology (MST)
This test assesses lower body strength and function. Participants are instructed to stand up from a chair and sit back down five times without using their arms. The MST measures movement dynamics. The primary measure is peak power score (W).
Measured: 24 weeks
Physical Function Measure: Six-Minute Walk Test (6MWT)
The 6MWT is a standardized submaximal exercise test used to assess functional aerobic capacity. Participants are instructed to walk as far as possible in six minutes along a flat, straight course. The total distance walked is recorded in feet. Longer walking distances indicate better aerobic capacity and endurance.
Measured: 24 weeks
Physical Function Measure: Hand Grip Strength using a Hydraulic Hand Dynamometer
Participants are instructed to squeeze the dynamometer with maximum effort, measured in kilograms. The highest value from multiple trials is recorded.
Measured: 24 weeks
Physical Function Measure: Short Form-12 (SF-12) Health Survey
The SF-12 is a standardized, self-administered questionnaire designed to assess overall health-related quality of life. It includes 12 items that measure physical and mental health components, generating Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores are standardized on a scale where higher values indicate better health status. Both PCS and MCS scores typically range from 0 to 100, with 0 indicating the poorest health and 100 indicating the best possible health status.
Measured: 24 weeks
Physical Function Measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue and Physical Function Domains
The PROMIS is a standardized set of self-reported questionnaires designed to measure health domains. This study includes the fatigue and physical function domains, which assess the participant's perceived level of tiredness and ability to perform daily physical activities. Responses generate standardized T-scores, calibrated to the general population. Higher fatigue T-scores indicate greater fatigue severity.
Measured: 24 weeks
Aging Biomarkers: Cellular Senescence Markers in Plasma
Cellular senescence markers are measured in plasma samples to assess biological aging and cellular stress. These markers may include proteins associated with the senescence-associated secretory phenotype (SASP). Quantification is performed using immunoassays. Higher levels of senescence markers indicate increased cellular senescence.
Measured: 24 weeks
Difference between biological and chronological age
Epigenetic clocks estimate biological age by analyzing DNA methylation patterns at specific CpG sites across the genome. Biological age estimates are compared to chronological age to assess aging acceleration or deceleration. Biological age greater than chronological age indicates accelerated biological aging and potential increased risk of morbidity and mortality. Primary measure is the difference (ΔAge) between biological and chronological ages = reported in years.
Measured: 24 weeks
Vascular Function Assessment: Reactive Hyperemia Index (RHI) using EndoPAT
The RHI is measured using the EndoPAT device, which assesses endothelial function by evaluating changes in digital pulse volume during reactive hyperemia. This non-invasive test involves occluding blood flow in one arm followed by release to induce vasodilation, with pulse amplitude recorded via finger probes. Lower RHI values suggest endothelial dysfunction and increased cardiovascular risk.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start1 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (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 Mayo ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a 24-week, open-label, pragmatic, randomized clinical trial. Participants will be randomized 1:1 to receive tirzepatide or semaglutide with a standard lifestyle intervention or a lifestyle intervention alone. Tirzepatide or semaglutide will be started at the lowest dose and titrated every four weeks, as tolerated, up to the maximum dose of 2.4 mg weekly for semaglutide and 15 mg weekly for tirzepatide. The choice of the medication will depend on patient's preference, cost, and drug availability. We will assess body composition, measurements of physical function, obtain a blood sample for the measurement of aging biomarkers, and perform vascular testing at different timepoints.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Daniela Hurtado Andrade, Mayo Clinic
- Investigators
- Maria D. Hurtado Andrade, M.D., Ph.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057310
- Sponsor's protocol ID
- 24-010834
- Status last verified
- Jul 2026
- First submitted
- 5 May 2025
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT07057310
- Acronym / sponsor ID
- 24-010834
- Keywords
- obesity, vascular function, aging, postmenopause, women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 9 Jul 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.
In postmenopausal women, obesity increases the risk of physical function decline, premature aging, and vascular dysfunction. Semaglutide and tirzepatide are potent obesity medications. The goal is to determine the effect of weight loss induced by the new generation of GLP-1 receptor agonists on physical function, aging biomarkers, and vascular function in postmenopausal women with obesity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a 24-week, open-label, pragmatic, randomized clinical trial. Participants will be randomized 1:1 to receive tirzepatide or semaglutide with a standard lifestyle intervention or a lifestyle intervention alone. Tirzepatide or semaglutide will be started at the lowest dose and titrated every four weeks, as tolerated, up to the maximum dose of 2.4 mg weekly for semaglutide and 15 mg weekly for tirzepatide. The choice of the medication will depend on patient's preference, cost, and drug availability. We will assess body composition, measurements of physical function, obtain a blood sample for the measurement of aging biomarkers, and perform vascular testing at different timepoints.
| Arm | Type | Receives |
|---|---|---|
| Weight loss medication and standard lifestyle intervention | Experimental | Drug: semaglutide or tirzepatide, Behavioral: Lifestyle modification interventionSubjects will receive tirzepatide or semaglutide in combination with a standard lifestyle intervention. |
| Standard lifestyle intervention only | Active comparator | Behavioral: Lifestyle modification interventionSubjects will receive standard of care lifestyle intervention only. |
Who may qualify
- Ages
- 46 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Postmenopausal women (with menopause defined as the cessation of menstrual periods for at least 12 months or history of bilateral oophorecomy)
- Age 46-60 years old
- BMI ≥ 30 kg/m2.
Key exclusion criteria (17 listed)
- Past or current use of menopausal hormone therapy
- Early or premature menopause
- History of chemically induced menopause
- Impaired renal function (GFR ≤29)
- Thyroid-stimulating hormone ≥7 with low free T4
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 |
|---|---|---|
| semaglutide or tirzepatideSemaglutide and tirzepatide will be dosed as per prescription labels | Drug | Weight loss medication and standard lifestyle intervention |
| Lifestyle modification interventionAll participants will be recommended the following: 1) low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day; 2) physical activity: a goal of 10,000 steps or more per day; 3) exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week; 4) limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.). | Behavioural | Standard lifestyle intervention only, Weight loss medication and standard lifestyle intervention |
Primary outcome
Physical Function Measure: Short Physical Performance Battery (SPPB) score.
Time frame: 24 weeks
The SPPB is a standardized test that evaluates lower extremity function using three components: balance tests (standing in various positions), gait speed (walking a short distance), and chair stand (repeated standing from a seated position). Each component is scored from 0 to 4; the total score ranges from 0 to 12. Higher scores represent better physical function.
Physical Function Measure: Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) performed on the Rehabilitation Artificial Physical Intelligence Database (RAPID) foot pressure mat
Time frame: 24 weeks
The mCTSIB assesses balance under four sensory conditions: eyes open/closed on firm and foam surfaces. Testing is performed while standing on the RAPID foot pressure mat, which captures center of pressure and postural sway data. The primary measure is average sway area of the four sensory conditions. The sway area is the area which is required to correct equilibrium, representing the total area covered by postural sway, measured in square centimeters (cm²).
Physical Function Measure: Standing Chest Throw Test with a 2-kg Weighted Ball using Motion Sensor Technology (MST)
Time frame: 24 weeks
This test evaluates upper body muscular power. Participants perform a two-handed chest throw of a 2-kg medicine ball from a standing position. The MST is used to record throw distance, velocity, and related performance metrics. The primary measure is Peak Power Score (W).
Physical Function Measure: Chair-to-Stand Tests using Motion Sensor Technology (MST)
Time frame: 24 weeks
This test assesses lower body strength and function. Participants are instructed to stand up from a chair and sit back down five times without using their arms. The MST measures movement dynamics. The primary measure is peak power score (W).
Physical Function Measure: Six-Minute Walk Test (6MWT)
Time frame: 24 weeks
The 6MWT is a standardized submaximal exercise test used to assess functional aerobic capacity. Participants are instructed to walk as far as possible in six minutes along a flat, straight course. The total distance walked is recorded in feet. Longer walking distances indicate better aerobic capacity and endurance.
Physical Function Measure: Hand Grip Strength using a Hydraulic Hand Dynamometer
Time frame: 24 weeks
Participants are instructed to squeeze the dynamometer with maximum effort, measured in kilograms. The highest value from multiple trials is recorded.
Physical Function Measure: Short Form-12 (SF-12) Health Survey
Time frame: 24 weeks
The SF-12 is a standardized, self-administered questionnaire designed to assess overall health-related quality of life. It includes 12 items that measure physical and mental health components, generating Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Scores are standardized on a scale where higher values indicate better health status. Both PCS and MCS scores typically range from 0 to 100, with 0 indicating the poorest health and 100 indicating the best possible health status.
Physical Function Measure: Patient-Reported Outcomes Measurement Information System (PROMIS) - Fatigue and Physical Function Domains
Time frame: 24 weeks
The PROMIS is a standardized set of self-reported questionnaires designed to measure health domains. This study includes the fatigue and physical function domains, which assess the participant's perceived level of tiredness and ability to perform daily physical activities. Responses generate standardized T-scores, calibrated to the general population. Higher fatigue T-scores indicate greater fatigue severity.
Aging Biomarkers: Cellular Senescence Markers in Plasma
Time frame: 24 weeks
Cellular senescence markers are measured in plasma samples to assess biological aging and cellular stress. These markers may include proteins associated with the senescence-associated secretory phenotype (SASP). Quantification is performed using immunoassays. Higher levels of senescence markers indicate increased cellular senescence.
Difference between biological and chronological age
Time frame: 24 weeks
Epigenetic clocks estimate biological age by analyzing DNA methylation patterns at specific CpG sites across the genome. Biological age estimates are compared to chronological age to assess aging acceleration or deceleration. Biological age greater than chronological age indicates accelerated biological aging and potential increased risk of morbidity and mortality. Primary measure is the difference (ΔAge) between biological and chronological ages = reported in years.
Vascular Function Assessment: Reactive Hyperemia Index (RHI) using EndoPAT
Time frame: 24 weeks
The RHI is measured using the EndoPAT device, which assesses endothelial function by evaluating changes in digital pulse volume during reactive hyperemia. This non-invasive test involves occluding blood flow in one arm followed by release to induce vasodilation, with pulse amplitude recorded via finger probes. Lower RHI values suggest endothelial dysfunction and increased cardiovascular risk.
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 20 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- 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.
Maria D. Hurtado Andrade, M.D., Ph.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing semaglutide or tirzepatide and Lifestyle modification intervention in people with Obesity and Menopause, run by Mayo Clinic 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 3 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 20 Jul 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical Function Measure: Short Physical Performance Battery (SPPB) score. (time frame: 24 weeks). The study lists 11 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 20 Jul 2026.