Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults (NCT06811324) | Clinical Trial Compass
RecruitingPhase 2
Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults
United States20 participantsStarted 2026-04-01
Plain-language 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.
Who can participate
Age range
50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Appendicular lean muscle mass
Timeframe: 6 months
2
Muscle Strength
Timeframe: 6 months
3
Lower Extremity Functional Capacity
Timeframe: 6 months
Trial details
NCT IDNCT06811324
SponsorThe University of Texas Health Science Center at San Antonio