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Trial · Interventional

RecruitingPhase 2Registry data

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

NCTNCT06811324 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00001208
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 2
Enrollment
20 participants (estimated)
Sponsor
The University of Texas Health Science Center at San Antonio · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Apr 2026
Primary completion
1 Apr 2027 (estimated)
Completion
1 Jun 2027 (estimated)
First posted
6 Feb 2025
Last update posted
15 Apr 2026
Conditions
Obesity Prevention · Sarcopenia in Elderly · Cardiovascular Function · GLP - 1 · Weight Loss

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202620272028
  1. Ph 2

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

    NCT06811324

    1 Apr 2026 to est. 1 Jun 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug

Arms1

  • Experimental

    Tirzepatide

    Tirzepatide self-administered once weekly by subcutaneous injection

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Appendicular lean muscle mass

    Time frame · 6 months

    Registry description

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

  2. Muscle Strength

    Time frame · 6 months

    Registry description

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

  3. Lower Extremity Functional Capacity

    Time frame · 6 months

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2021

19 results

Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.

Frías et al. 2021The New England journal of medicinecited by 1,535

PMID 34170647DOI 10.1056/nejmoa2107519PUB-34170647

Full text at the publisher19 results
Publisher pageSee results (19)

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

Corrected

Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial.

Wadden et al. 2023Nature medicinecited by 364

PMID 37840095PMC10667099DOI 10.1038/s41591-023-02597-wPUB-37840095

CC BY
Download PDFRead the notice

Indexing hint: Review · 2022

Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes.

Kaneko et al. 2022TouchREVIEWS in endocrinologycited by 20

PMID 35949358PMC9354517DOI 10.17925/ee.2022.18.1.10PUB-35949358

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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