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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 46
Maximum Age: 60
Healthy Volunteers: t
View:

• Females

• Age 46-60 years old.

• BMI ≥30 kg/m2 or BMI ≥27 kg/m2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).

• Presence of bothersome hot flashes (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).

• Hot flashes must be present for \>30 days prior to study entry.

• Willingness to self-inject drug

• Provided informed consent to be part of the study.

• Willingness and capability to follow an individualized hypocaloric diet designed to achieve an approximate energy deficit of 500 kcal/day relative to estimated total daily energy requirements. Daily energy requirements will be calculated using Harris-Benedict equation to estimate resting energy expenditure and multiplied by a sedentary physical activity factor of 1.2. Prescribed daily caloric intake will not be less than 1,000 kcal/day. Participants must also be willing to engage in at least 150 minutes per week of moderate-intensity or greater physical activity.

Locations
United States
Florida
Mayo Clinic in Florida
RECRUITING
Jacksonville
Contact Information
Primary
Tina Taaffe
taaffe.christina@mayo.edu
904-953-4769
Backup
Lauren Uy
uy.lauren@mayo.edu
904-953-5337
Time Frame
Start Date: 2026-04-08
Estimated Completion Date: 2027-09-18
Participants
Target number of participants: 40
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic

This content was sourced from clinicaltrials.gov

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