Actively Recruiting
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Led by Mayo Clinic · Updated on 2026-03-24
40
Participants Needed
1
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
CONDITIONS
Official Title
The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Postmenopausal women defined as 12 months of no menstrual periods, or 6 months with high follicle-stimulating hormone (FSH) levels, or 6 weeks after surgical removal of ovaries
- Age between 46 and 60 years
- Body mass index (BMI) of 30 or more, or 27 or more with obesity-related health issues
- Experiencing 28 or more bothersome hot flashes per week
- Hot flashes present for more than 30 days before joining the study
- Able and willing to participate fully, including self-injecting the study drug
- Provided informed consent
- Willing and able to follow a low-calorie diet with about 500 kcal/day energy deficit and perform at least 150 minutes of moderate exercise weekly
You will not qualify if you...
- Current use of menopausal hormone therapy
- Use within the past 4 weeks or planned use of estrogen-containing contraceptives or hormone therapy
- Use of vaginal estrogen, androgens, or progestogens
- Current treatment for menopausal symptoms with cognitive behavioral therapy or hypnosis
- Current use of fezolinetant
- Menopause caused by cancer treatments
- Impaired kidney function with GFR 30 ml/min/1.73 m² or less
- Thyroid-stimulating hormone above 7 with low free T4
- 10-year risk for atherosclerotic cardiovascular disease over 7.5%
- Active inflammatory, autoimmune, infectious, liver, gastrointestinal, cancer, or uncontrolled psychiatric disease
- Recent weight change over 5% in past 3 months or weight fluctuation of 20 pounds in past 6 months
- Use of other obesity medications in past 3 months
- History of bariatric or related surgeries within specified timeframes
- Recent use of medications that may cause weight gain
- Recent use of systemic glucocorticoids for more than 2 weeks in past 3 months
- Contraindications to GLP-1 receptor agonists such as personal or family history of specific thyroid cancers or syndromes
- Participation in another clinical study with an investigational product within last 30 days
- Planned surgery requiring general anesthesia during or soon after the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224
Actively Recruiting
Research Team
A
Aubri Robbins, BHSc
CONTACT
A
Alysha Stephens
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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