NCT07218445 The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
| NCT ID | NCT07218445 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Mayo Clinic |
| Condition | Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-08 |
| Primary Completion | 2027-09-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2026-04-08 with a primary completion date of 2027-09-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 Criteria 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. Exclusion Criteria 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. 5. Menopause as a result of cancer treatments. 6. Impaired renal function (GFR ≤30 ml/min/1.73 m²). 7. Thyroid-stimulating hormone ≥7 with low free T4. 8. 10-year ASCVD risk \> 7.5%. 9. Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease. 10. \>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). 11. Other obesity medication was used within the past 3 months. 12. History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \> 1 year before screening). 13. Past or intended endoscopic and/or device-based therapy or removal within last six months. 14. Use of weight gain-promoting medications (including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers), unless the participant has been receiving the medication at a stable dose for ≥3 months prior to enrollment and has maintained a stable body weight during that time 15. Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months. 16. Female who is pregnant, breastfeeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method. 17. 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. 18. 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. 19. Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.
Contact & Investigator
Chrisandra Shufelt, MD
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT07218445 clinical trial?
This trial is open to female participants only, aged 46 Years or older, up to 60 Years, studying Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07218445 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07218445 currently recruiting?
Yes, NCT07218445 is actively recruiting participants. Contact the research team at taaffe.christina@mayo.edu for enrollment information.
Where is the NCT07218445 trial being conducted?
This trial is being conducted at Jacksonville, United States.
Who is sponsoring the NCT07218445 clinical trial?
NCT07218445 is sponsored by Mayo Clinic. The principal investigator is Chrisandra Shufelt, MD at Mayo Clinic. The trial plans to enroll 40 participants.
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