GLP-1 Peptide Atlas, by Delfa

RecruitingPhase 4

The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity

The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study

Lead sponsor

Mayo Clinic

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight, Reproductive / infertility

Key I/E criteria

•BMI ≥30•Female

Primary endpoints

•Vasomotor Symptoms Frequency•Vasomotor Symptom Severity•Aging Biomarkers

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07218445

Org study ID25-001692

Timeline

Milestones

Study first posted2025-10-20actual

Last update posted2026-03-24actual

Primary completion2027-09-18estimated

Study completion2027-09-18estimated

Study start2026-04estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightReproductive / infertility

Eligibility

Who can enroll

Minimum age46 Years

Maximum age60 Years

SexFemale

Healthy volunteersAccepted

Inclusion criteria

•Postmenopausal women defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels > 40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.

•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 (≥ 28 episodes per week and of sufficient severity to prompt patients to seek therapeutic interventions).

•Hot flashes must be present for >30 days prior to study entry.

•Ability to participate in all portions of the study, including willingness to self-inject drug

•Provided informed consent to be part of the study.

•Willingness and capability to follow a hypocaloric diet, consisting of an energy deficit of approximately 500 kcal/day compared to baseline total energy expenditure, and composed of 30% from fat, 20% from protein, and 50% of carbohydrate. In addition to performing at least 150 min/week of physical activity

Exclusion criteria

•Current treatment with menopausal hormone therapy.

•Any current (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.

•Current treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.

•Current use of fezolinetant.

•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.

•10-year ASCVD risk > 7.5%.

•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 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.

•Current or recent (within 3 months) use of medications that may cause weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.

•Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.

•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.

•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.

•Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Cardiometabolic biomarkers

Other (unclassified)

Glycemic / diabetes

Heart failure

Patient-reported / QoL

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Change in Cardiometabolic Parameters: Fasting Glucose

Time frame:Baseline, 24 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Changes in Cardiometabolic Parameters: HbA1C

Time frame:Baseline, 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

1 endpoint

Secondary/protocol endpoint

Change in Physical Function Measure: Six-Minute Walk Test (6MWT)

Time frame:Baseline, 24 weeks

6-minute walk distance

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints

Secondary/protocol endpoint

Change in Reactive hyperemic index

Time frame:Baseline, 12 weeks and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Pulse Wave Velocity

Time frame:Baseline, 12 weeks, and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Cardiometabolic Parameters: Blood Pressure

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Changes in Cardiometabolic Parameters: Lipoprotein profile

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Changes in Cardiometabolic Parameters: hsCRP

Time frame:Baseline, 24 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

1 endpoint

Primary/protocol endpoint

Change in Vasomotor Symptom Severity

Time frame:Baseline, 24 weeks

change from baseline, improvement

Other clinical outcomes

6 endpoints

Primary/protocol endpoint

Change in Vasomotor Symptoms Frequency

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Physical Function Measure: Short Physical Performance Battery (SPPB) score.

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Physical Function Measure: Standing Chest Throw Test with a 2-kg Weighted Ball using Motion Sensor Technology (MST)

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Physical Function Measure: Chair-to-Stand Tests using Motion Sensor Technology (MST)

Time frame:Baseline, 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Physical Function Measure: Hand Grip Strength using a Hydraulic Hand Dynamometer

Time frame:Baseline, 24 weeks

change from baseline, improvement

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Aging Biomarkers: Cellular Senescence Markers in Plasma

Time frame:24 weeks

concentration, descriptive

Primary/protocol endpoint/low confidence

Difference between biological and chronological age

Time frame:24 weeks

descriptive

Secondary/protocol endpoint/low confidence

Change in Augmentation Index percentage

Time frame:Baseline, 12 weeks, and 24 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.