Tirzepatide for Menopausal Hot Flashes and Biological Aging in Women with Obesity
This study is looking at how a drug called tirzepatide affects hot flashes (vasomotor symptoms) and biological aging in post-menopausal women who also have obesity. You might be able to join if you are a woman between 46 and 60 years old and have gone through menopause. Participants will receive either tirzepatide or a placebo (an inactive substance that looks like the drug) through weekly injections, with the dose gradually increasing. Everyone in the study will also follow a low-calorie diet. Researchers will measure changes in your hot flash frequency and severity, and look at markers of aging in your blood over 24 weeks to see if the treatment is successful. The current recruitment status for this study is unclear.
- Study design
- This interventional study plans to enroll 40 participants. It compares tirzepatide to a placebo.
- What's involved
- Participants will receive weekly subcutaneous injections of either tirzepatide or placebo, with doses increasing every 4 weeks. You will also follow a low-calorie diet for 24 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures outcomes at 24 weeks, indicating follow-up during this period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Chrisandra Shufelt, MD · PRINCIPAL_INVESTIGATOR · Mayo Clinic
Who to contact
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What this trial measures
- Change in Vasomotor Symptoms FrequencyBaseline, 24 weeks
Change in the frequency of self-reported daily average vasomotor symptoms from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and 2 weeks at the end of the study.
- Change in Vasomotor Symptom SeverityBaseline, 24 weeks
Change in self-reported daily vasomotor symptom severity from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and at the end of the study. Severity will be classified as follows: Mild, sensation of heat without sweating/dampness; Moderate: sensation of heat with sweating/dampness, but able to continue current activity. May briefly fan yourself; Severe: sensation of intense heat with sweating causing disruption of current activity.
- Aging Biomarkers: Cellular Senescence Markers in Plasma24 weeks
Cellular senescence markers are measured in plasma samples to assess biological aging and cellular stress. These markers may include proteins associated with the senescence-associated secretory phenotype (SASP). Quantification is performed using immunoassays. Higher levels of senescence markers indicate increased cellular senescence.
- Difference between biological and chronological age24 weeks
Epigenetic clocks estimate biological age by analyzing DNA methylation patterns at specific CpG sites across the genome. Biological age estimates are compared to chronological age to assess aging acceleration or deceleration. Biological age greater than chronological age indicates accelerated biological aging and potential increased risk of morbidity and mortality. Primary measure is the difference (ΔAge) between biological and chronological ages = reported in years.