Who is eligible for clinical trial NCT07218445?

Participants must meet protocol criteria for Obesity. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07218445 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-16

The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity (NCT07218445)

🟢 Recruiting Phase4 💊 Investigational Drug / Biologic Sponsor: Mayo Clinic

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (24 items).

Location: Mayo Clinic in Florida — Jacksonville, Florida

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Females
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 (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).
Hot flashes must be present for \>30 days prior to study entry.
Willingness to self-inject drug
Provided informed consent to be part of the study.
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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria
Current or recent use (past 4 weeks) treatment with menopausal hormone therapy.
Any current, recent use (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 or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.
Current or recent use (past 4 weeks) of fezolinetant or elinzanetant.
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Mayo Clinic in Florida — Jacksonville, Florida

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗