Actively Recruiting

Phase 2
Age: 50Years +
All Genders
NCT06811324

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

Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-04-15

20

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and postmenopausal women aged 50 years or older.
  • Body Mass Index (BMI) 30 kg/m8.
  • Untreated HbA1c less than 6.5% at baseline.
  • Willingness and ability to comply with all study procedures, including fasting requirements.
  • Able to provide informed consent and participate in all study assessments.
Not Eligible

You will not qualify if you...

  • Active diagnosis of type 2 diabetes mellitus, including use of glucose-lowering medications or HbA1c 6.5% or higher.
  • Body Mass Index (BMI) 40 kg/m8 or higher.
  • Moderate to severe gastroesophageal reflux disease.
  • Inability to comply with the treatment protocol or understand the consent form.
  • Chronic Kidney Disease Stage 4.
  • Elevated liver enzymes: AST greater than 33 U/L or ALT greater than 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 allergic reactions to Tirzepatide or its components.
  • Known serious allergic reactions to any GLP-1 receptor agonist therapies.
  • Current treatment with GLP-1 receptor agonist therapy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

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Research Team

S

Suha Soni

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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