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New treatment option for Obesity
Official title The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity
ClinicalTrials.gov ID: NCT07218445
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 46 to 60, women only. Healthy volunteers may be eligible.
You may be able to join if
- Postmenopausal women defined as 12 months of spontaneous amenorrhea, or 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone...
- 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...
- 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.
You likely can't join 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.
See the full eligibility 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 46 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.