Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults
Recruiting
Phase 2Interventional Study
Obesity PreventionSarcopenia in ElderlyCardiovascular FunctionGLP - 1Weight Loss
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
50 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Other
Participants needed
20 (estimated)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Who this trial is looking for
This trial is looking for older adults with obesity who are interested in how a new medication called tirzepatide affects muscle health and function. Participants will take tirzepatide for 6 months and undergo various assessments during this time.
Are You a Good Fit for This Trial?
Rules you outChronic Kidney Disease Stage 4Type 2 Diabetes
You may be able to join if
I am 50 years or older.
I have a BMI of at least 30.
I have not been diagnosed with type 2 diabetes.
I can follow study procedures and fasting requirements.
I am able to give informed consent.
You may not be able to join if
I have been diagnosed with type 2 diabetes.
I have a BMI of 40 or more.
I suffer from moderate to severe gastroesophageal reflux disease.
I cannot follow the treatment protocol or understand the consent form.
I have chronic kidney disease stage 4.
I have elevated liver enzymes.
I am currently pregnant.
I have a personal or family history of certain thyroid cancers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 cardiov…
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.
Trial Locations
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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…
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
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