The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausa… (NCT07218445) | Clinical Trial Compass
RecruitingPhase 4
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
United States40 participantsStarted 2026-04
Plain-language summary
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
Who can participate
Age range46 Years – 60 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria
* 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
Exclusion Criteria
* 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 cognit…
What they're measuring
1
Change in Vasomotor Symptoms Frequency
Timeframe: Baseline, 24 weeks
2
Change in Vasomotor Symptom Severity
Timeframe: Baseline, 24 weeks
3
Aging Biomarkers: Cellular Senescence Markers in Plasma
Timeframe: 24 weeks
4
Difference between biological and chronological age