ObesityPhase 4NCT07218445
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
A Phase 4 study testing Tirzepatide in people with Obesity and Menopause Hot Flashes, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging. Read more about this study
- Who is it for?
- Ages 46 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Menopause Hot Flashes
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2026to 18 Sep 2027
- Phase
- Phase 4
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females
- Age 46-60 years old.
- BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
- Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).
- Hot flashes must be present for >30 days prior to study entry.
- Willingness to self-inject drug
- Provided informed consent to be part of the study.
- Willingness and capability to follow an individualized hypocaloric diet designed to achieve an approximate energy deficit of 500 kcal/day relative to estimated total daily energy requirements. Daily energy requirements will be calculated using Harris-Benedict equation to estimate resting energy expenditure and multiplied by a sedentary physical activity factor of 1.2. Prescribed daily caloric intake will not be less than 1,000 kcal/day. Participants must also be willing to engage in at least 150 minutes per week of moderate-intensity or greater physical activity.
Who cannot join
- Current or recent use (past 4 weeks) treatment with menopausal hormone therapy.
- Any current, recent use (past 4 weeks), or planned use of:
- Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).
- Vaginal estrogen.
- Androgens.
- Progestogens.
Show all 22Show fewer
- Current or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.
- Current or recent use (past 4 weeks) of fezolinetant or elinzanetant.
- Menopause as a result of cancer treatments.
- Impaired renal function (GFR ≤30 ml/min/1.73 m²).
- Thyroid-stimulating hormone ≥7 with low free T4.
- Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease.
- >5% change in weight during the 3 months prior to screening and, or eight fluctuation of ≥20 pounds within the past 6 months (self-report).
- Other obesity medication was used within the past 3 months.
- History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed > 1 year before screening).
- Past or intended endoscopic and/or device-based therapy or removal within last six months.
- Use of weight gain-promoting medications (including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers), unless the participant has been receiving the medication at a stable dose for ≥3 months prior to enrollment and has maintained a stable body weight during that time
- Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.
- 16. Female who is pregnant, breastfeeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- 15. Contraindications to GLP-1 receptor agonist therapy as per Tirzepatide (Zepbound ®) label, including a personal or family history of medullary thyroid carcinoma; a history or diagnosis of multiple endocrine neoplasia syndrome type 2; known hypersensitivity to tirzepatide or any of its excipients.
- 16. Currently enrolled in another clinical study involving an investigational product or participated in one and received treatment (active or placebo) in the last 30 days.
- 17. Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.
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
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Jessica Hoag, 904-953-5290, hoag.jessica@mayo.edu
Lauren Uy, 904-953-5337, uy.lauren@mayo.edu
About this study
Official title: The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
- Conditions
- Obesity, Menopause Hot Flashes
- Being tested
- Tirzepatide, Placebo
- Keywords
- Hot flashes, menopause, Tirzepatide, GLP
- Medical subject headings
- Obesity, Hot Flashes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg.
Participants will be asked to follow lifestyle interventions:
- Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day
- Physical activity: a goal of 10,000 steps or more per day
- Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week
- Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).
PlaceboDrug
A placebo for Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg.
Participants will be asked to follow lifestyle interventions:
- Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day
- Physical activity: a goal of 10,000 steps or more per day
- Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week
- Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Experimental | Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vasomotor Symptoms Frequency
Change in the frequency of self-reported daily average vasomotor symptoms from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and 2 weeks at the end of the study.
Measured: Baseline, 24 weeks
Change in Vasomotor Symptom Severity
Change in self-reported daily vasomotor symptom severity from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and at the end of the study. Severity will be classified as follows:
Mild, sensation of heat without sweating/dampness; Moderate: sensation of heat with sweating/dampness, but able to continue current activity. May briefly fan yourself; Severe: sensation of intense heat with sweating causing disruption of current activity.
Measured: Baseline, 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
Secondary outcomes (14)
Change in Reactive hyperemic index
Vascular function will be measured using the EndoPAT device to assesses reactive hyperemia index (RHI) from baseline to week 24 on treatment or placebo. RHI is automatically calculated through a computer algorithm by following the equation: [(tested arm-post occlusion/tested arm-baseline)/(control arm-post occlusion/control arm-baseline)] × baseline correction factor. Endothelial dysfunction is defined as having an RHI ratio of equal or less than 1.67.
Measured: Baseline, 12 weeks and 24 weeks
Change in Augmentation Index percentage
Augmentation Index (AIx): AIX uses applanation tonometry of the radial artery pulse, calibrated to resting brachial systolic and diastolic pressures (SphygmoCor XCEL, Medtronic, Minneapolis, MN). Aortic systolic, diastolic, and pulse pressures will be derived from a synthesized aortic waveform using a validated mathematical transfer function. Augmentation pressure, reflecting the difference between aortic systolic pressure and the inflection point caused by the reflected wave, is influenced by arterial stiffness as well as factors like heart rate and ejection dynamics. AIx is calculated as augmentation pressure divided by aortic pulse pressure × 100%, adjusted to a heart rate of 75 bpm (AIx@75 bpm). Measurements will be performed in duplicate and averaged.
Measured: Baseline, 12 weeks, and 24 weeks
Change in Pulse Wave Velocity
SphygmoCor estimates central arterial stiffness by calculating the speed at which the pressure wave travels between the carotid and femoral arteries using applanation tonometry and reported as the pulse wave velocity (PWV); PWV m/s
Measured: Baseline, 12 weeks, and 24 weeks
Change in Cardiometabolic Parameters: Blood Pressure
Change in cardiometabolic parameters including blood pressure from baseline to week 24 on treatment or placebo. Measured in mmhg
Measured: Baseline, 24 weeks
Change in Cardiometabolic Parameters: Fasting Glucose
Change in cardiometabolic parameters including fasting glucose from baseline to week 24 on treatment or placebo. Measured in mg/dL
Measured: Baseline, 24 weeks
Changes in Cardiometabolic Parameters: HbA1C
Change in cardiometabolic parameters including HbA1C from baseline to week 24 on treatment or placebo. Measured in %
Measured: Baseline, 24 weeks
Changes in Cardiometabolic Parameters: Lipoprotein profile
Change in cardiometabolic parameters including Lipoprotein profile from baseline to week 24 on treatment or placebo. Measured in mg/dL
Measured: Baseline, 24 weeks
Changes in Cardiometabolic Parameters: hsCRP
Change in cardiometabolic parameters including hsCRP from baseline to week 24 on treatment or placebo. Measured in mg/L
Measured: Baseline, 24 weeks
Change in 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: Baseline, 24 weeks
Change in 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: Baseline, 24 weeks
Change in 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: Baseline, 24 weeks
Change in 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: Baseline, 24 weeks
Change in 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: Baseline, 24 weeks
Change in 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: Baseline, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start8 Apr 2026
- Primary completion18 Sep 2027 (estimated)
- Study completion18 Sep 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chrisandra L. Shufelt, MD, Mayo Clinic
- Investigators
- Chrisandra Shufelt, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07218445
- Sponsor's protocol ID
- 25-001692
- Status last verified
- Aug 2026
- First submitted
- 3 Oct 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No