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

Phase 2

Not yet recruiting

• Conditions: Obesity Prevention; Sarcopenia in Elderly; Cardiovascular Function; GLP - 1; Weight Loss; Hispanic or Latino; Minorities
• Interventions: Drug: Tirzepatide

• Registration Number: NCT06811324
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

Obesity and type 2 diabetes mellitus (T2DM) represent major public health concerns in the aging Hispanic 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 in the Hispanic community has been on the rise since FDA approval was issued, however the effects of tirzepatide use on functional outcomes in older Hispanic 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 Hispanic 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 Hispanic adults with obesity. This study is particularly important because Hispanic individuals are disproportionately affected by obesity and related health issues, including type 2 diabetes and cardiovascular conditions, which can lead to rapid aging and increased frailty. 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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Last Update Submitted: 2025-01-31
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06
• Study Start: 2025-03-01
• Primary Completion: 2026-01-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tirzepatide	Tirzepatide	Tirzepatide self-administered once weekly by subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Appendicular lean muscle mass	6 months	Appendicular lean muscle mass assessed at baseline and at 6-month follow-up by dual-energy X-ray absorptiometry (DEXA)
Muscle Strength	6 months	Muscle strength assessed by isokinetic and isometric testing using Biodex dynamometry at baseline and at 6-month follow-up.
Lower Extremity Functional Capacity	6 months	Functional capacity will be measured using the 6-minute walk test (6MWT) at baseline and 6-month follow up visit.

Trial Locations

Locations (1)

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States