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

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

September 16, 2025

Primary Completion Date

September 18, 2027

Study Completion Date

September 18, 2027

Conditions
ObesityMenopause Hot Flashes
Interventions
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.)."

Trial Locations (1)

32224

Mayo Clinic in Florida, Jacksonville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER