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

✓ 1. Females
✓ 2. Age 46-60 years old.
✓ 3. BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).
✓ 4. 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).
✓ 5. Hot flashes must be present for \>30 days prior to study entry.
✓ 6. Willingness to self-inject drug
✓ 7. Provided informed consent to be part of the study.
✓ 8. 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.

✕ 1. Current or recent use (past 4 weeks) treatment with menopausal hormone therapy.
✕ 2. Any current, recent use (past 4 weeks), or planned use of:
✕ 1. Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).
✕ 2. Vaginal estrogen.
✕ 3. Androgens.
✕ 4. Progestogens.
✕ 3. Current or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.
✕ 4. Current or recent use (past 4 weeks) of fezolinetant or elinzanetant.

Jacksonville

Source: ClinicalTrials.gov · NCT07218445 · last updated 2026-08-18