Clinical trial

Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06811324

Recruiting nowPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age50 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionObesity Prevention, Sarcopenia in Elderly, Cardiovascular Function, GLP - 1, Weight Loss

Full registry 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

Treatments and study arms

Tirzepatide

Drug

Once weekly tirzepatide starting at 2.5 mg/weekly, with dose escalation monthly by 2.5 mg to a target dose of 10 mg/weekly or maximum tolerated

Primary outcomes

Appendicular lean muscle mass6 months

Appendicular lean muscle mass assessed at baseline and at 6-month follow-up by dual-energy X-ray absorptiometry (DEXA)

Muscle Strength6 months

Muscle strength assessed by isokinetic and isometric testing using Biodex dynamometry at baseline and at 6-month follow-up.

Lower Extremity Functional Capacity6 months

Functional capacity will be measured using the 6-minute walk test (6MWT) at baseline and 6-month follow up visit.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Texas Health Science Center at San Antonio🇺🇸 San Antonio, Texas, United States

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Shreya RaoContact