NCT07218445

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

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

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: Female
• Age: 46 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Obesity
• Menopause Hot Flashes

Interventions

Type	Name	Description
DRUG	Tirzepatide	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.).
DRUG	Placebo	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.).

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-09-18
• Completion: 2027-09-18
• First posted: 2025-10-20
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study