DRUG
semaglutide or tirzepatide
Semaglutide and tirzepatide will be dosed as per prescription labels
Status
Enrolling by invitation
Phase
Phase 4
Enrollment
30
Locations
1
Results
Not posted
Publications
0
Study summary
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.
Interventions
DRUG
Semaglutide and tirzepatide will be dosed as per prescription labels
BEHAVIORAL
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.).
Timeline
First posted
Jul 9, 2025
Study start
May 1, 2025
Primary completion
Dec 31, 2026
Study completion
Mar 31, 2027
Results posted
Not reported
Registry updated
Jul 20, 2026
Outcomes
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.
Not reported in the indexed record.
Eligibility
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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