Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

This study is a pilot, single-arm, open-label clinical trial to evaluate the effects of Tirzepatide on muscle mass, strength, and vascular health among older adults with obesity. This study is set in South Texas, where rates of obesity and related health issues, including type 2 diabetes and cardiovascular conditions, exceed national averages and where aging-related diseases are on the rise. Tirzepatide is a new FDA approved medication that promotes weight loss and improves health by targeting specific pathways in the body. While it has been shown to be effective in managing weight and blood sugar levels, there is less information about the kind of weight loss it induces, and how weight loss impacts measures of muscle mass, strength and mobility. This is especially concerning for older adults, as losing muscle mass can lead to weakness, falls, and disability.

Inclusion criteria

• Men and postmenopausal women aged 50 years or older.
• Body Mass Index (BMI) ≥30 kg/m².
• Untreated HbA1c <6.5% at baseline.
• Willingness and ability to comply with all study procedures, including fasting requirements for certain visits.
• Able to provide informed consent and participate in all study assessments.

Exclusion criteria

• Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.
• Body Mass Index (BMI) ≥ 40 kg/m².
• Moderate to severe gastroesophageal reflux disease based on patient history.
• Inability to comply with the treatment protocol or to understand the consent form.
• Chronic Kidney Disease (CKD) Stage 4.
• Aspartate aminotransferase (AST) > 33 U/L or alanine aminotransferase (ALT) > 36 U/L.
• Active pregnancy.
• Personal or family history of medullary thyroid carcinoma.
• Personal or family history of multiple endocrine neoplasia type 2 syndrome.
• Personal history of gastroparesis.
• Personal history of diabetic retinopathy.
• Known serious hypersensitivity, including anaphylaxis and angioedema, to Tirzepatide or any of its excipients.
• Known serious hypersensitivity, including anaphylaxis and angioedema, to any GLP-1 receptor agonist class of therapies.
• Concomitant treatment with GLP-1 receptor agonist therapy