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

NCT ID: NCT07218445

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-16
• Study Completion Date: 2027-09-18

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tirzepatide

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

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: 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.).

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.).

Interventions

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.).

Intervention Type: 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.).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.
• 10-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.
• History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed > 1 year before screening).
• Past or intended endoscopic and/or device-based therapy or removal within last six months.
• Current or recent (within 3 months) use of medications that may cause weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
• Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.
• Contraindications to GLP-1 receptor agonist therapy as per Tirzepatide (Zepbound ®) label, including a personal or family history of medullary thyroid carcinoma; a history or diagnosis of multiple endocrine neoplasia syndrome type 2; known hypersensitivity to tirzepatide or any of its excipients.
• Currently enrolled in another clinical study involving an investigational product, or participated in one and received treatment (active or placebo) in the last 30 days.
• Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.

• Minimum Eligible Age: 46 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Chrisandra L. Shufelt, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chrisandra Shufelt, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials/cls-20589486

Mayo Clinic Clinical Trials

Other Identifiers

25-001692

Identifier Type: -

Identifier Source: org_study_id