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

Purpose

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

Eligibility

Eligible Ages
Between 46 Years and 60 Years
Eligible Sex
Female
Accepts Healthy Volunteers
Yes

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.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tirzepatide 		Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations
  • 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.).
Placebo Comparator
Placebo 		Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations
  • 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.).

Recruiting Locations

Mayo Clinic in Florida
Jacksonville, Florida 32224
Contact:
Aubri Robbins, BHSc
904-953-4712
wooten.aubri@mayo.edu

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Aubri Robbins, BHSc
904-953-4712
wooten.aubri@mayo.edu