RecruitingObesityMenopause Hot Flashes

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

Eligible age

46–60 yrs

Accepts

Women

Locations

1 state

Healthy volunteers

Yes

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The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.

Sponsor: Mayo Clinic

✓ 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

✕ 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.

Jacksonville

Source: ClinicalTrials.gov · NCT07218445 · last updated 2026-06-05