GLP-1 Agonists for Obesity in Menopause

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: Anti-obesity medications

Disqualifiers: Diabetes, Cardiovascular disease, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two medications, semaglutide and tirzepatide (both GLP-1 agonists), can aid weight loss and improve physical health in postmenopausal women with obesity. The researchers aim to determine if weight loss with these medications can enhance physical function, reduce signs of aging, and improve cardiovascular health. Participants will receive either one of the medications along with a lifestyle program or the lifestyle program alone. Ideal candidates are postmenopausal women with a BMI of 30 or higher who have not used hormone therapy. As a Phase 4 trial, this study involves treatments already FDA-approved and proven effective, seeking to further understand their benefits for more patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you have used other anti-obesity medications or certain supplements affecting weight in the past 3 months.

What is the safety track record for these treatments?

Studies have shown that both semaglutide and tirzepatide are generally well-tolerated in people with obesity. Research indicates that semaglutide can lead to significant weight loss, with some studies noting about a 15% reduction in body weight over two years. This treatment also improves insulin use and blood sugar control.

Tirzepatide has also been linked to significant weight loss. Specifically, one study reported up to an 18.7% reduction in body weight for participants. This medication, when combined with lifestyle changes, is effective for women in menopause, similar to its effects on younger women.

Both medications belong to a group of drugs that help manage blood sugar. They have been used safely in other conditions, like type 2 diabetes. Most side effects are mild and may include nausea or digestive issues, but these often decrease over time. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about semaglutide and tirzepatide for obesity in menopause because these treatments offer a fresh approach compared to standard lifestyle changes and weight-loss medications. Both semaglutide and tirzepatide are GLP-1 agonists, which work by mimicking a hormone that helps control appetite and blood sugar levels, potentially leading to significant weight loss. Unlike older medications, which often focus on suppressing appetite or speeding up metabolism, these drugs offer the dual benefit of appetite regulation and improved metabolic control. Additionally, tirzepatide has a unique dual-action mechanism, as it also targets another hormone involved in insulin regulation, which might enhance its effectiveness for weight loss.

What is the effectiveness track record for semaglutide and tirzepatide in treating obesity in postmenopausal women?

This trial will compare the effects of semaglutide and tirzepatide, both GLP-1 agonists, on weight loss in postmenopausal women. Research has shown that semaglutide can lead to significant weight loss, with some studies noting up to a 20% reduction in body weight. Evidence suggests semaglutide is effective for women at all stages of menopause. Similarly, tirzepatide has demonstrated impressive results, with reports of about a 17% reduction in body weight. Both medications not only aid in weight loss but also improve waist size and body measurements, which can lower health risks. Overall, semaglutide and tirzepatide have proven effective for weight loss in postmenopausal women with obesity. Participants in this trial will receive either semaglutide or tirzepatide combined with a standard lifestyle intervention, or they will receive the standard lifestyle intervention alone. ^{2 4 5 6 7}

Who Is on the Research Team?

Maria D. Hurtado Andrade, M.D., Ph.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for postmenopausal women who are dealing with obesity. It aims to help them improve their physical and vascular health. To join, participants should be experiencing menopause and have a body mass index (BMI) that classifies as obese.

Inclusion Criteria

BMI ≥ 30 kg/m2

I am a woman who has not had a period for at least 12 months or have had both ovaries removed.

I am between 46 and 60 years old.

Exclusion Criteria

I or someone in my family has had medullary thyroid cancer.

I use a wheelchair for mobility.

I am experiencing vision loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide or semaglutide in combination with a standard lifestyle intervention or standard lifestyle intervention only

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Semaglutide
• Tirzepatide

Trial Overview The study is testing the effects of lifestyle changes combined with new medications called semaglutide or tirzepatide on weight loss, physical function, aging signs, and blood vessel health in these women.

How Is the Trial Designed?

Group I: Weight loss medication and standard lifestyle intervention Experimental Treatment 2 Interventions

Subjects will receive tirzepatide or semaglutide in combination with a standard lifestyle intervention.

Group II: Standard lifestyle intervention only Active Control 1 Intervention

Subjects will receive standard of care lifestyle intervention only.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11209769/

Weight loss response to semaglutide in postmenopausal ... In postmenopausal women with overweight or obesity treated with semaglutide, hormone therapy use was associated with an improved weight loss response.

2. journals.lww.com journals.lww.com/menopausejournal/fulltext/2024/04000/weight_loss_response_to_semaglutide_in.4.aspx

Weight loss response to semaglutide in postmenopausal ... In postmenopausal women with overweight or obesity treated with semaglutide, HT use was associated with an improved weight loss response.

3. liebertpub.com liebertpub.com/doi/10.1089/met.2024.0124

Effectiveness of Low Doses of Semaglutide on Weight Loss ... To date, no specific data on women in their menopause have been published. We found that mean weight loss was around 5% either with menopausal ...

4. nyp.org nyp.org/advances/article/women-in-menopause-benefit-from-glp-1-weight-loss-medications-as-much-as-younger-women

Women in Menopause Benefit From GLP-1 Weight-Loss ... Whether she is premenopausal, perimenopausal, or postmenopausal, the medication results in an approximately 20% weight reduction. Because the ...

5. nature.com nature.com/articles/s41591-022-02026-4

Two-year effects of semaglutide in adults with overweight ... The mean weight loss of ~15% achieved with semaglutide 2.4 mg at week 104 in STEP 5 exceeds weight loss reported at similar time points in ...

6. news-medical.net news-medical.net/health/Semaglutide-and-weight-loss-in-menopause.aspx

Semaglutide and Weight Loss in Menopause Semaglutide could help postmenopausal women lose weight, restore insulin sensitivity, and achieve blood sugar control.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38446869/

Weight loss response to semaglutide in postmenopausal ... In postmenopausal women with overweight or obesity treated with semaglutide, HT use was associated with an improved weight loss response.