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Tirzepatide for Muscle and Vascular Health in Older Adults with Obesity

This study is looking at how Tirzepatide, a medication approved for type 2 diabetes and obesity, affects muscle and blood vessel health in older adults who are obese. Researchers want to see if Tirzepatide can help improve muscle mass, strength, and how well people can move. You might be able to join if you are 50 or older, have a Body Mass Index (BMI) of 30 or higher, and your blood sugar (HbA1c) is below 6.5% without treatment. The study will measure changes in your arm and leg muscle mass, muscle strength, and how well you can use your legs after 6 months to see if the treatment is successful. The current status of this study is unclear.

Study design
This is a pilot study, meaning it's a small-scale test, with one group of participants (single-arm) and everyone knows what treatment they are receiving (open-label). It plans to enroll 20 participants.
What's involved
You would receive Tirzepatide once weekly, starting at 2.5 mg and increasing monthly to a target of 10 mg or the highest dose you can tolerate. You will need to follow all study procedures, including fasting for some visits.
Compensation
Not stated in the trial record.
Follow-up
Your muscle mass, strength, and functional capacity will be measured at 6 months after starting the intervention.

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NCT06811324

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

Recruiting
PHASE2Ages 50+Interventional
The University of Texas Health Science Center at San Antonio
~20 participants
Updated 2026-04-15 on ClinicalTrials.gov
What's tested:Tirzepatide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Appendicular lean muscle mass
Measured over 6 months
+2 more outcomes measured

Conditions

Obesity Prevention
Sarcopenia in Elderly
Cardiovascular Function
GLP - 1
Weight Loss

Explore related trials

ObesitySarcopenia

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Shreya Rao, MD, MPH · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
  • Elena Volpi, MD, PhD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center at San Antonio
  • Tiffany Cortes, MD · STUDY_DIRECTOR · The University of Texas Health Science Center at San Antonio

Who to contact

Suha Soni
[email protected]
(210)450-3333
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • 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.