NCT06811324

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

The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Adults

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging community. Tirzepatide, a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist recently approved for the treatment of T2DM and obesity has been shown to be effective at reducing weight, improving markers of T2DM control, and improving cardiovascular health. Utilization of tirzepatide among older adults has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older adults with obesity are not well established. Recent studies show that weight loss caused by tirzepatide may be driven by substantial loss of lean muscle mass, which may contribute to weakness and frailty, particularly among older adults. The proposed pilot study aims to evaluate how treatment with tirzepatide for 6 months affects muscle mass and function among older adults, and if changes in muscle mass are linked to changes in functional status over the same time period.

Detailed description

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.

Conditions

• Obesity Prevention
• Sarcopenia in Elderly
• Cardiovascular Function
• GLP - 1
• Weight Loss

Interventions

Type	Name	Description
DRUG	Tirzepatide	Once weekly tirzepatide starting at 2.5 mg/weekly, with dose escalation monthly by 2.5 mg to a target dose of 10 mg/weekly or maximum tolerated

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-04-01
• Completion: 2027-06-01
• First posted: 2025-02-06
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study