Tirzepatide for Hot Flashes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether tirzepatide, a medication, can reduce hot flashes and slow biological aging. Participants will receive either tirzepatide or a placebo for 24 weeks while following lifestyle changes such as diet and exercise. The trial seeks postmenopausal women who experience bothersome hot flashes at least 28 times a week. Ideal candidates have experienced these symptoms for over 30 days and are willing to self-inject the treatment. As a Phase 4 trial, tirzepatide is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications to join the trial, especially if you are currently using menopausal hormone therapy, estrogen, androgens, progestogens, or certain other treatments for menopausal symptoms. The trial does not specify a washout period, but you should discuss your current medications with the study team to see if they are allowed.
What is the safety track record for tirzepatide?
Research has shown that tirzepatide is generally well-tolerated. In one study, women using tirzepatide lost a significant amount of weight without major problems. However, some people reported side effects like nausea or mild stomach issues. More serious side effects are rare but can include severe symptoms like seizures. Staying informed and reporting any concerns to healthcare professionals is important. Since this treatment is in a Phase 4 trial, it has been approved for other uses, suggesting it is generally safe.12345
Why are researchers enthusiastic about this study treatment?
Most treatments for hot flashes, like hormone replacement therapy and certain antidepressants, work by addressing hormonal imbalances or altering neurotransmitter levels. But tirzepatide, originally developed for diabetes, works differently by targeting the GLP-1 and GIP receptors, which can influence the body's metabolic processes. Researchers are excited about tirzepatide because it could offer a novel way to manage hot flashes by potentially regulating body temperature through its unique mechanism of action. This approach might provide relief for those who don't respond well to existing treatments or who can't use hormone-based therapies.
What evidence suggests that tirzepatide might be an effective treatment for hot flashes?
Research has shown that tirzepatide primarily aids in weight loss. Studies have demonstrated a significant reduction in body weight and waist size among women with obesity. Although not initially linked to hot flashes, some patients have reported changes in these symptoms while taking tirzepatide. However, these changes are not officially recognized as side effects. In this trial, participants will receive either tirzepatide or a placebo to explore how tirzepatide might influence hot flashes and aging, alongside its established benefits for weight management.26789
Who Is on the Research Team?
Chrisandra Shufelt, MD
Principal Investigator
Mayo Clinic
Are You a Good Fit for This Trial?
This trial is for postmenopausal women aged 46-60 with obesity and frequent, bothersome hot flashes. Participants must be willing to follow a specific diet and exercise plan, have not had significant weight changes recently, are not on hormone therapy or certain other medications, and do not have certain medical conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either tirzepatide or placebo for 24 weeks, along with standard lifestyle modification recommendations
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor