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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 6 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how taking tirzepatide for 6 months affects muscle size and how well muscles work. It is for adults age 50 or older with obesity who do not have type 2 diabetes. It also looks at whether muscle changes are linked to changes in physical ability.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women age 50 or older. Women must have gone through menopause.
  • A body mass index (BMI), a measure of weight compared with height, of 30 or higher.
  • An HbA1c blood test below 6.5% at the start, without blood sugar treatment. This test shows average blood sugar.
  • Willing and able to follow all study steps, including going without food before some visits.
  • Able to understand and agree to join the study and complete all study tests.

Who can't join

  • Type 2 diabetes, defined as taking blood sugar medicines or having an HbA1c of 6.5% or higher; or a BMI of 40 or higher.
  • Moderate or severe acid reflux, or a history of gastroparesis, when the stomach empties too slowly.
  • Unable to follow the treatment plan or understand the study consent form.
  • Stage 4 chronic kidney disease, meaning severe kidney damage; or liver blood tests with AST above 33 U/L or ALT above 36 U/L.
  • Currently pregnant.
  • You or a family member has had medullary thyroid cancer or multiple endocrine neoplasia type 2, a condition that can cause tumors in hormone-making glands.
  • A history of diabetic retinopathy, which is eye damage caused by diabetes.
  • A known serious allergy to tirzepatide, its ingredients, or any GLP-1 medicine; or currently taking a GLP-1 medicine, a type of medicine used for blood sugar or weight control.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX