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Effects of Tirzepatide on Muscle and Vascular Health in Obese Older Adults Phase 2 20 Novel Treatment

Recruiting
Clinical Trial NCT06811324 is designed to study Other for Obesity Prevention, Sarcopenia in Elderly, Cardiovascular Function, GLP - 1, Weight Loss. It is a Phase 2 interventional study that is recruiting, having started on February 15, 2026, with plans to enroll 20 participants. Led by The University of Texas Health Science Center at San Antonio, it is expected to complete by June 1, 2027. The latest data from ClinicalTrials.gov was last updated on January 16, 2026.
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. Util...Show More
Detailed Description
This study is a pilot, single-arm, open-label clinical trial to evaluate the effects of Tirzepatide on muscle mass, strength, and vascular health among older adults with obesity. This study is set in South Texas, where rates of obesity and related health issues, including type 2 diabetes and cardiovascular conditions, exceed national averages and where aging-related diseases are on the rise. Tirzepatide is a new FDA ...Show More
Official Title

The Effects of Tirzepatide Use on Muscle and Vascular Function Among Obese Older Adults

Conditions
Obesity PreventionSarcopenia in ElderlyCardiovascular FunctionGLP - 1Weight Loss
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • STUDY00001208
NCT ID Number
NCT06811324
Start Date (Actual)
2026-02-15
Last Update Posted
2026-01-16
Completion Date (Estimated)
2027-06-01
Enrollment (Estimated)
20
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
Tirzepatide
GLP-1
Obesity
Sarcopenia
Cardiovascular Function
Primary Purpose
Other
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalTirzepatide
Tirzepatide self-administered once weekly by subcutaneous injection
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 Measures
Outcome MeasureMeasure DescriptionTime Frame
Appendicular lean muscle mass
Appendicular lean muscle mass assessed at baseline and at 6-month follow-up by dual-energy X-ray absorptiometry (DEXA)
6 months
Muscle Strength
Muscle strength assessed by isokinetic and isometric testing using Biodex dynamometry at baseline and at 6-month follow-up.
6 months
Lower Extremity Functional Capacity
Functional capacity will be measured using the 6-minute walk test (6MWT) at baseline and 6-month follow up visit.
6 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
50 Years
Eligible Sexes
All
  • 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.

  • 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
The University of Texas Health Science Center at San Antonio logoThe University of Texas Health Science Center at San Antonio
Study Central Contact
Contact: Suha Soni, (210)450-3333, [email protected]
1 Study Locations in 1 Countries

Texas

University of Texas Health Science Center at San Antonio, San Antonio, Texas, 78229, United States
Shreya Rao, Contact, [email protected]
Recruiting