Recruiting
Phase 2

Tirzepatide

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT06811324

Conditions

Obesity Prevention

Sarcopenia in Elderly

Cardiovascular Function

GLP - 1

Weight Loss

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Study Details

Brief summary:

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.

Conditions

Obesity Prevention

Sarcopenia in Elderly

Cardiovascular Function

GLP - 1

Weight Loss

Study ID

NCT06811324

Start date

Apr 1, 2026

Status verified date

Jan, 2026

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Tirzepatide

Tirzepatide self-administered once weekly by subcutaneous injection

Interventions

Tirzepatide

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 outcome measure

  • Appendicular lean muscle mass [ Time Frame: 6 months ]
  • Muscle Strength [ Time Frame: 6 months ]
  • Lower Extremity Functional Capacity [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Suha Soni

(210)450-3333BCRU@uthscsa.edu

Locations

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Shreya Rao

raos4@uthscsa.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Apr 15, 2026

Last verified

Jan, 2026

Keywords

  • Tirzepatide
  • GLP-1
  • Obesity
  • Sarcopenia
  • Cardiovascular Function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-04-15.