[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609735":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":62,"collaborators":25,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":25,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":25,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Mayo Clinic","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tirzepatide","EXPERIMENTAL","Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations",[13],"Drug: Tirzepatide",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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.\n\nParticipants will be asked to follow lifestyle interventions:\n\n* Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day\n* Physical activity: a goal of 10,000 steps or more per day\n* Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week\n* Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"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.\n\nParticipants will be asked to follow lifestyle interventions:\n\n* Low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day\n* Physical activity: a goal of 10,000 steps or more per day\n* Exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week\n* Limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).",[15],[30],{"name":31,"affiliation":5,"role":32},"Chrisandra Shufelt, MD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Tina Taaffe","CONTACT","904-953-4769","taaffe.christina@mayo.edu",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Lauren Uy","904-953-5337","uy.lauren@mayo.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Mayo Clinic in Florida","RECRUITING","Jacksonville","Florida","32224","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-81.65565,30.33218,{"lat":56,"lon":55},[59,60,61],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":32,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Chrisandra L. Shufelt, MD","Principal Investigator","100609735","phase-4-the-effect-of-tirzepatide-on-menopausal-vasomotor-symptoms-and-biological-aging-in-post-menopausal-women-with-obesity-100609735",false,"NCT07218445","The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity","The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study","Inclusion Criteria\n\n* Postmenopausal women defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone (FSH) levels \\> 40 mIU\u002Fml, or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.\n* Age 46-60 years old.\n* BMI ≥30 kg\u002Fm2 or BMI ≥27 kg\u002Fm2 in the presence of adiposity-associated diseases (hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease).\n* Presence of bothersome hot flashes (≥ 28 episodes per week and of sufficient severity to prompt patients to seek therapeutic interventions).\n* Hot flashes must be present for \\>30 days prior to study entry.\n* Ability to participate in all portions of the study, including willingness to self-inject drug\n* Provided informed consent to be part of the study.\n* Willingness and capability to follow a hypocaloric diet, consisting of an energy deficit of approximately 500 kcal\u002Fday 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\u002Fweek of physical activity\n\nExclusion Criteria\n\n* Current treatment with menopausal hormone therapy.\n* Any current (past 4 weeks) or planned use of:\n\n  * Estrogen-containing contraceptive methods or menopausal hormone therapy (oral, transdermal, high dose vaginal ring, injection, pellets).\n  * Vaginal estrogen.\n  * Androgens.\n  * Progestogens.\n* Current treatment for menopausal symptoms with cognitive behavioral therapy and\u002For hypnosis.\n* Current use of fezolinetant.\n* Menopause as a result of cancer treatments.\n* Impaired renal function (GFR ≤30 ml\u002Fmin\u002F1.73 m²).\n* Thyroid-stimulating hormone ≥7 with low free T4.\n* 10-year ASCVD risk \\> 7.5%.\n* Active inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignancy, or uncontrolled psychiatric disease.\n* \\>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).\n* Other obesity medication used within the past 3 months.\n* History of bariatric surgery. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty performed \\> 1 year before screening).\n* Past or intended endoscopic and\u002For device-based therapy or removal within last six months.\n* Current or recent (within 3 months) use of medications that may cause weight gain, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.\n* Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.\n* 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.\n* 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.\n* Planned surgical procedures requiring general anesthesia or sedation during the study or within 2 weeks following the last dose of study drug.",true,"FEMALE","46 Years","60 Years",{"count":77,"type":78},40,"ESTIMATED","INTERVENTIONAL",[81],"PHASE4","The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.",[84,85],"Obesity","Menopause Hot Flashes",[87,88,9,89],"Hot flashes","menopause","GLP","2026-06-03",{"date":92,"type":93},"2026-06-05","ACTUAL",{"date":95,"type":93},"2026-04-08",{"date":97,"type":78},"2027-09-18",{"name":5,"class":6},1]