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

NCT07218445 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-001692
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hot flashes; menopause; Tirzepatide; GLP

Outcome Measures

Primary Outcomes (4)

• Change in Vasomotor Symptoms Frequency

  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.

  Baseline, 24 weeks

• Change in Vasomotor Symptom Severity

  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.

  Baseline, 24 weeks

• Aging Biomarkers: Cellular Senescence Markers in Plasma

  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.

  24 weeks

• Difference between biological and chronological age

  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.

  24 weeks

Secondary Outcomes (14)

• Change in Reactive hyperemic index

  Baseline, 12 weeks and 24 weeks

• Change in Augmentation Index percentage

  Baseline, 12 weeks, and 24 weeks

• Change in Pulse Wave Velocity

  Baseline, 12 weeks, and 24 weeks

• Change in Cardiometabolic Parameters: Blood Pressure

  Baseline, 24 weeks

• Change in Cardiometabolic Parameters: Fasting Glucose

  Baseline, 24 weeks

Study Arms (2)

Tirzepatide

EXPERIMENTAL

Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations

Drug: Placebo

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.).

Tirzepatide

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.).

Placebo

Eligibility Criteria

• Age: 46 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Postmenopausal women defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \> 40 mIU/ml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
• 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 (≥ 28 episodes per week and of sufficient severity to prompt patients to seek therapeutic interventions).
• Hot flashes must be present for \>30 days prior to study entry.
• Ability to participate in all portions of the study, including willingness to self-inject drug
• Provided informed consent to be part of the study.
• Willingness and capability to follow a hypocaloric diet, consisting of an energy deficit of approximately 500 kcal/day compared to baseline total energy expenditure, and composed of 30% from fat, 20% from protein, and 50% of carbohydrate. In addition to performing at least 150 min/week of physical activity

You may not qualify if:

• Current treatment with menopausal hormone therapy.
• Any current (past 4 weeks) or planned use of:
• Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).
• Vaginal estrogen.
• Androgens.
• Progestogens.
• Current treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.
• Current use of fezolinetant.
• Menopause as a result of cancer treatments.
• Impaired renal function (GFR ≤30 ml/min/1.73 m²).
• Thyroid-stimulating hormone ≥7 with low free T4.
• year ASCVD risk \> 7.5%.
• Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease.
• \>5% change in weight during the 3 months prior to screening and, or eight fluctuation of ≥20 pounds within the past 6 months (self-report).
• Other obesity medication used within the past 3 months.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Obesity; Hot Flashes

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Chrisandra Shufelt, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aubri Robbins, BHSc

CONTACT

904-953-4712; wooten.aubri@mayo.edu

Alysha Stephens

CONTACT

904-953-7846; ford.alysha@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 3, 2025
• First Posted: October 20, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 18, 2027
• Study Completion (Estimated): September 18, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)