NCT06811324 Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults
| NCT ID | NCT06811324 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Obesity Prevention |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2027-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-04-01 with a primary completion date of 2027-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Shreya Rao, MD, MPH
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT06811324 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Obesity Prevention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06811324 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06811324 currently recruiting?
Yes, NCT06811324 is actively recruiting participants. Contact the research team at BCRU@uthscsa.edu for enrollment information.
Where is the NCT06811324 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT06811324 clinical trial?
NCT06811324 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Shreya Rao, MD, MPH at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 20 participants.
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