NCT06811324RecruitingPhase 2
Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults
The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Adults
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 31 Jan 2025
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2027
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Diseases
- Obesity
- NCT number
- NCT06811324
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 1 Apr 2026 to the primary completion date, 1 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant treatment with GLP-1 receptor agonist therapy
Other illness
- Moderate to severe gastroesophageal reflux disease based on patient history.
- Chronic Kidney Disease (CKD) Stage 4.
- 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.
Lab values
- Active diagnosis of type 2 diabetes mellitus (T2DM), defined by active use of glucose-lowering medications or hemoglobin A1c ≥ 6.5%.
- Aspartate aminotransferase (AST) \> 33 U/L or alanine aminotransferase (ALT) \> 36 U/L.
Other
- Body Mass Index (BMI) ≥ 40 kg/m².
- Inability to comply with the treatment protocol or to understand the consent form.
- Active pregnancy.
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Texas Health Science Center at San Antonio Coordinator of this site? Confirm its status | San Antonio | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.