Aging Well: Targeting Obesity With GLP-1 Agonists to Enhance Physical and Vascular Health in Postmenopausal Women

NCT ID: NCT07057310

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2027-03-31

Brief Summary

In postmenopausal women, obesity increases the risk of physical function decline, premature aging, and vascular dysfunction. Semaglutide and tirzepatide are potent obesity medications. The goal is to determine the effect of weight loss induced by the new generation of GLP-1 receptor agonists on physical function, aging biomarkers, and vascular function in postmenopausal women with obesity.

Conditions

Obesity; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Weight loss medication and standard lifestyle intervention

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

Group Type: EXPERIMENTAL

semaglutide or tirzepatide

Intervention Type: DRUG

Semaglutide and tirzepatide will be dosed as per prescription labels

Lifestyle modification intervention

Intervention Type: BEHAVIORAL

All participants will be recommended the following: 1) low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day; 2) physical activity: a goal of 10,000 steps or more per day; 3) exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week; 4) limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).

Standard lifestyle intervention only

Subjects will receive standard of care lifestyle intervention only.

Group Type: ACTIVE_COMPARATOR

Lifestyle modification intervention

Intervention Type: BEHAVIORAL

All participants will be recommended the following: 1) low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day; 2) physical activity: a goal of 10,000 steps or more per day; 3) exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week; 4) limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).

Interventions

semaglutide or tirzepatide

Semaglutide and tirzepatide will be dosed as per prescription labels

Intervention Type: DRUG

Lifestyle modification intervention

All participants will be recommended the following: 1) low-calorie diet based on their predicted by Harris Benedict resting energy expenditure minus 500 kcal per day; 2) physical activity: a goal of 10,000 steps or more per day; 3) exercise: a goal of 150 minutes or more of moderate-intensity aerobic activity (cardiovascular exercise) per week; 4) limited consumption of liquid calories (i.e. sodas, juices, alcohol, etc.).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Postmenopausal women (with menopause defined as the cessation of menstrual periods for at least 12 months or history of bilateral oophorecomy)
• Age 46-60 years old
• BMI ≥ 30 kg/m2.

Exclusion Criteria

• Past or current use of menopausal hormone therapy
• Early or premature menopause
• History of chemically induced menopause
• Impaired renal function (GFR ≤29)
• Thyroid-stimulating hormone ≥7 with low free T4
• Diabetes
• Cardiovascular disease
• Elevated blood pressure (>170/>95)
• Uncontrolled co-morbidities including inflammatory, autoimmune, infectious, hepatic, gastrointestinal, malignant, or psychiatric disease
• >5% change in weight during the 3 months prior to screening
• Other anti-obesity medication use within the past 3 months
• History of bariatric surgery
• History of malignant neoplasms within the past 5 years prior to screening
• Current use of supplements known to affect weight
• Personal or family history of medullary thyroid cancer.
• Wheelchair bound
• Vision loss

• Minimum Eligible Age: 46 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Maria Daniela Hurtado Andrade

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

24-010834

Identifier Type: -

Identifier Source: org_study_id