Status:
ACTIVE_NOT_RECRUITING
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Lead Sponsor:
Mayo Clinic
Conditions:
Obesity
Menopause Hot Flashes
Eligibility:
FEMALE
46-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 18 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07218445
Start Date
September 16 2025
End Date
September 18 2027
Last Update
October 30 2025
Active Locations (1)
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1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224