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

Not Applicable

Active, not recruiting

• Conditions: Obesity; Menopause Hot Flashes
• Interventions: Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT07218445
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-09-16
• Status Verified: 2025-10
• Study First Submitted: 2025-10-03
• Study First Submitted QC: 2025-10-16
• Last Update Submitted: 2025-10-16
• Study First Posted: 2025-10-20
• Last Update Posted: 2025-10-20
• Primary Completion: 2027-09-18
• Study Completion: 2027-09-18

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tirzepatide	Tirzepatide	Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations
Placebo	Placebo	Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations

Primary Outcome Measures

Name	Time	Method
Change in Vasomotor Symptoms Frequency	Baseline, 24 weeks	Change in the frequency of self-reported daily average vasomotor symptoms from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and 2 weeks at the end of the study.
Change in Vasomotor Symptom Severity	Baseline, 24 weeks	Change in self-reported daily vasomotor symptom severity from baseline to 24 weeks. Vasomotor symptoms will be captured for 2 weeks at baseline and at the end of the study. Severity will be classified as follows: Mild, sensation of heat without sweating/dampness; Moderate: sensation of heat with sweating/dampness, but able to continue current activity. May briefly fan yourself; Severe: sensation of intense heat with sweating causing disruption of current activity.
Aging Biomarkers: Cellular Senescence Markers in Plasma	24 weeks	Cellular senescence markers are measured in plasma samples to assess biological aging and cellular stress. These markers may include proteins associated with the senescence-associated secretory phenotype (SASP). Quantification is performed using immunoassays. Higher levels of senescence markers indicate increased cellular senescence.
Difference between biological and chronological age	24 weeks	Epigenetic clocks estimate biological age by analyzing DNA methylation patterns at specific CpG sites across the genome. Biological age estimates are compared to chronological age to assess aging acceleration or deceleration. Biological age greater than chronological age indicates accelerated biological aging and potential increased risk of morbidity and mortality. Primary measure is the difference (ΔAge) between biological and chronological ages = reported in years.

Secondary Outcome Measures

Name	Time	Method
Change in Vascular Function	Baseline, 24 weeks	Vascular function will be measured using the EndoPAT device to assesses reactive hyperemia index (RHI) from baseline to week 24 on treatment or placebo. RHI is automatically calculated through a computer algorithm by following the equation: \[(tested arm-post occlusion/tested arm-baseline)/(control arm-post occlusion/control arm-baseline)\] × baseline correction factor. Endothelial dysfunction is defined as having an RHI ratio of \<1.67.
Change in Cardiometabolic Parameters: Blood Pressure	Baseline, 24 weeks	Change in cardiometabolic parameters including blood pressure from baseline to week 24 on treatment or placebo. Measured in mmhg
Change in Cardiometabolic Parameters: Fasting Glucose	Baseline, 24 weeks	Change in cardiometabolic parameters including fasting glucose from baseline to week 24 on treatment or placebo. Measured in mg/dL
Changes in Cardiometabolic Parameters: HbA1C	Baseline, 24 weeks	Change in cardiometabolic parameters including HbA1C from baseline to week 24 on treatment or placebo. Measured in %
Changes in Cardiometabolic Parameters: Lipoprotein profile	Baseline, 24 weeks	Change in cardiometabolic parameters including Lipoprotein profile from baseline to week 24 on treatment or placebo. Measured in mg/dL
Changes in Cardiometabolic Parameters: hsCRP	Baseline, 24 weeks	Change in cardiometabolic parameters including hsCRP from baseline to week 24 on treatment or placebo. Measured in mg/L

Trial Locations

Locations (1)

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States