Weight-Loss drug may cool menopause hot flashes and reverse aging clock
NCT ID NCT07218445
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This pilot study tests whether tirzepatide, a medication used for diabetes and weight loss, can reduce the frequency and severity of hot flashes in postmenopausal women with obesity. Researchers will also measure markers of biological aging, like cellular senescence and epigenetic clocks, to see if the drug slows the aging process. The study involves 40 women aged 46–60 who have bothersome hot flashes and a BMI of 30 or higher. Participants will take tirzepatide for 24 weeks and report their symptoms while providing blood samples for aging analysis.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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46 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224, United States
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