Tirzepatide effects on muscle and blood-vessel health in older adults with obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a pilot, single-arm, open-label 6-month trial testing tirzepatide in older adults with obesity to measure changes in muscle mass, muscle strength, mobility, and vascular health. Participants are men and postmenopausal women aged 50+ with BMI 30–39.9 kg/m² and without active type 2 diabetes, recruited at a single center in San Antonio, Texas. The study will collect body composition, strength testing, mobility measures, and vascular assessments before and after treatment to determine the nature of weight loss and any associated loss of lean muscle. Results will help clarify whether tirzepatide-related weight loss in older adults is accompanied by clinically meaningful declines in muscle or vascular function.

Why it matters

Who can join: the full rules

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

Where it's running

• University of Texas Health Science Center at San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Shreya Rao, MD, MPH — The University of Texas Health Science Center at San Antonio
• Study coordinator: Suha Soni
• Email: BCRU@uthscsa.edu
• Phone: (210)450-3333

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.