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

Aktiv, nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07218445 untersucht Behandlung im Zusammenhang mit Fettleibigkeit, Menopause Hot Flashes. Diese interventionsstudie der Phase 4 hat den Status aktiv, nicht rekrutierend und startete am 16. September 2025. Es ist geplant, 40 Teilnehmer aufzunehmen. Durchgeführt von Mayo-Klinik wird der Abschluss für 18. September 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 30. Oktober 2025 aktualisiert.
Kurzbeschreibung
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
Offizieller Titel

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

Erkrankungen
FettleibigkeitMenopause Hot Flashes
Weitere Studien-IDs
  • 25-001692
NCT-Nummer
NCT07218445
Studienbeginn (tatsächlich)
2025-09-16
Zuletzt aktualisiert
2025-10-30
Studienende (vorauss.)
2027-09-18
Geplante Rekrutierung
40
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Aktiv, nicht rekrutierend
Stichwörter
Hot flashes
menopause
Tirzepatide
GLP
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellTirzepatide
Participants will receive tirzepatide for 24 weeks, in addition to standard lifestyle modification recommendations
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-VergleichspräparatPlacebo
Participants will receive a placebo for 24 weeks, in addition to standard lifestyle modification recommendations
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.).
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
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
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Change in Vascular Function
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.
Baseline, 24 weeks
Change in Cardiometabolic Parameters: Blood Pressure
Change in cardiometabolic parameters including blood pressure from baseline to week 24 on treatment or placebo. Measured in mmhg
Baseline, 24 weeks
Change in Cardiometabolic Parameters: Fasting Glucose
Change in cardiometabolic parameters including fasting glucose from baseline to week 24 on treatment or placebo. Measured in mg/dL
Baseline, 24 weeks
Changes in Cardiometabolic Parameters: HbA1C
Change in cardiometabolic parameters including HbA1C from baseline to week 24 on treatment or placebo. Measured in %
Baseline, 24 weeks
Changes in Cardiometabolic Parameters: Lipoprotein profile
Change in cardiometabolic parameters including Lipoprotein profile from baseline to week 24 on treatment or placebo. Measured in mg/dL
Baseline, 24 weeks
Changes in Cardiometabolic Parameters: hsCRP
Change in cardiometabolic parameters including hsCRP from baseline to week 24 on treatment or placebo. Measured in mg/L
Baseline, 24 weeks
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
46 Years
Zugelassene Geschlechter
Weiblich
Akzeptiert gesunde Freiwillige
Ja
  • 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

  • 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.

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Verantwortliche Partei
Chrisandra L. Shufelt, MD, Hauptprüfer, Principal Investigator, Mayo Clinic
Keine Kontaktdaten vorhanden
1 Studienstandorte in 1 Ländern

Florida

Mayo Clinic in Florida, Jacksonville, Florida, 32224, United States