The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT07218445
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
46 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Tirzepatide — DRUG
    Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg. Participants will be asked to follow lifestyle interventions: * Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day * Physical activity: a goal of 10,000 steps or more per day * Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week * Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).
  • Placebo — DRUG
    A placebo for Tirzepatide will be administered with a starting dose of 2.5 mg weekly, subcutaneously injected. The dose will increase by 2.5 mg every 4 weeks until reaching 15 mg. Participants will be asked to follow lifestyle interventions: * Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day * Physical activity: a goal of 10,000 steps or more per day * Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week * Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).

Study Details

The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.

Key Dates

Start date
Apr 8, 2026
Status verified
Jun 2026
Primary completion
Sep 18, 2027
Completion
Sep 18, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations
  • Placebo Comparator: Placebo
    Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations

Primary Outcome Measure

Change in Vasomotor Symptoms Frequency [ Time Frame: Baseline, 24 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224
Tina Taaffe
[email protected]
904-953-4769
Lauren Uy
[email protected]
904-953-5337
Chrisandra Shufelt, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Jacksonville, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Mayo Clinic in Florida· Jacksonville, FL

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