Tirzepatide effects on muscle and blood-vessel health in older adults with obesity
The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Adults
This trial will try tirzepatide for six months in adults 50 and older with obesity but without diabetes to see if it changes muscle mass, strength, and blood vessel health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06811324 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are men and postmenopausal women aged 50 or older with BMI ≥30 and <40 kg/m², HbA1c below 6.5%, not taking glucose-lowering medications, and able to attend study visits and consent to procedures.
Not a fit: People with active type 2 diabetes, BMI ≥40 kg/m², advanced kidney disease (CKD stage 4), significant liver enzyme elevations, pregnancy, or a history of medullary thyroid carcinoma or MEN2 are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could help doctors weigh the benefits of tirzepatide-induced weight loss against possible muscle loss and guide safer use in older adults with obesity.
How similar studies have performed: Large trials have shown tirzepatide produces substantial weight loss and cardiometabolic benefits, but its specific effects on muscle mass and functional outcomes in older adults are not well established and some reports suggest notable lean-mass loss.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Antonio, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.