What this study is
The purpose of this study is to determine the effect of tirzepatide on vasomotor symptoms and on measures of biological aging.
What's being tested
- Tirzepatide
Intervention · 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
Intervention · 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.).
Study details
- Official title
- The Effect of Tirzepatide on Menopausal Vasomotor Symptoms and Biological Aging in Post-menopausal Women With Obesity: A Pilot Study
- Sponsor
- Mayo Clinic
- Conditions
- Obesity · Menopause Hot Flashes
- Enrolling
- 40 people
- Starts
- 2026-04-08
- Est. completion
- 2027-09-18
- Design
- Quadruple-blind, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 46 Years – 60 YearsSex FEMALEHealthy volunteers AcceptedYou may qualify if
- Females
- 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 (an average of ≥ 28 episodes during a consecutive 2-week period with symptom severity sufficient to have prompted the participant to seek therapeutic treatment).
- Hot flashes must be present for >30 days prior to study entry.
- Willingness to self-inject drug
- Provided informed consent to be part of the study.
- Willingness and capability to follow an individualized hypocaloric diet designed to achieve an approximate energy deficit of 500 kcal/day relative to estimated total daily energy requirements. Daily energy requirements will be calculated using Harris-Benedict equation to estimate resting energy expenditure and multiplied by a sedentary physical activity factor of 1.2. Prescribed daily caloric intake will not be less than 1,000 kcal/day. Participants must also be willing to engage in at least 150 minutes per week of moderate-intensity or greater physical activity.
You can't join if
- Current or recent use (past 4 weeks) treatment with menopausal hormone therapy.
- Any current, recent use (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 or recent use (past 4 weeks) treatment for menopausal symptoms with cognitive behavioral therapy and/or hypnosis.
- Current or recent use (past 4 weeks) of fezolinetant or elinzanetant.
- 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.
- 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 was 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.
- Use of weight gain-promoting medications (including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers), unless the participant has been receiving the medication at a stable dose for ≥3 months prior to enrollment and has maintained a stable body weight during that time
- Current or recent (within 3 months) use of chronic systemic glucocorticoid therapy for over 2 weeks within the past 3 months.
- Female who is pregnant, breastfeeding, or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMayo Clinic in Florida
Jacksonville, Florida, United States
- Jessica Hoag · Contact904-953-5290hoag.jessica@mayo.edu
- Lauren Uy · Contact904-953-5337uy.lauren@mayo.edu
- Chrisandra Shufelt, MD · Principal investigator
Recruiting
Study team
Sponsor
Mayo Clinic
Study ID 25-001692
Principal investigator
Chrisandra Shufelt, MD
Mayo Clinic
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.