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

Mayo Clinic

Status and phase: Invitation-only; Phase 4

Conditions: Menopause; Obesity

Treatments: Drug: semaglutide or tirzepatide; Behavioral: Lifestyle modification intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07057310

24-010834

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 46 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Weight loss medication and standard lifestyle intervention

Experimental group

Description:

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

Treatment:

Behavioral: Lifestyle modification intervention

Drug: semaglutide or tirzepatide

Standard lifestyle intervention only

Active Comparator group

Description:

Subjects will receive standard of care lifestyle intervention only.

Treatment:

Behavioral: Lifestyle modification intervention