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

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.