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Obesity PreventionPhase 2NCT06811324

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

A Phase 2 study testing Tirzepatide in people with Obesity Prevention and Sarcopenia in Elderly, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
1 Apr 2026to 1 Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Suha Soni contact

(210)450-3333

BCRU@uthscsa.edu

United States1 site, 1 recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

    Shreya Rao, raos4@uthscsa.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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 approved medication that promotes weight loss and improves health by targeting specific pathways in the body. While it has been shown to be effective in managing weight and blood sugar levels, there is less information about the kind of weight loss it induces, and how weight loss impacts measures of muscle mass, strength and mobility. This is especially concerning for older adults, as losing muscle mass can lead to weakness, falls, and disability.

Being tested
Tirzepatide
Keywords
Tirzepatide, GLP-1, Obesity, Sarcopenia, Cardiovascular Function
Medical subject headings
Weight Loss, Obesity, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called Zepbound, LY3298176

    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

Study groups in NCT06811324
Study groupRoleWhat they receive
TirzepatideExperimentalTirzepatide self-administered once weekly by subcutaneous injection
Receives: Drug: Tirzepatide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Appendicular lean muscle mass

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

    Measured: 6 months

  2. Muscle Strength

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

    Measured: 6 months

  3. Lower Extremity Functional Capacity

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2025
  2. Study start1 Apr 2026
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Jun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06811324
Sponsor's protocol ID
STUDY00001208
Status last verified
Jan 2026
First submitted
31 Jan 2025
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data that underlie the results reported will be available in accordance with ICMJE policy.

Publications

  • Marx N, Husain M, Lehrke M, Verma S, Sattar N. GLP-1 Receptor Agonists for the Reduction of Atherosclerotic Cardiovascular Risk in Patients With Type 2 Diabetes. Circulation. 2022 Dec 13;146(24):1882-1894. doi: 10.1161/CIRCULATIONAHA.122.059595. Epub 2022 Dec 12.

    PubMed 36508493

  • Clark RV, Walker AC, O'Connor-Semmes RL, Leonard MS, Miller RR, Stimpson SA, Turner SM, Ravussin E, Cefalu WT, Hellerstein MK, Evans WJ. Total body skeletal muscle mass: estimation by creatine (methyl-d3) dilution in humans. J Appl Physiol (1985). 2014 Jun 15;116(12):1605-13. doi: 10.1152/japplphysiol.00045.2014. Epub 2014 Apr 24.

    PubMed 24764133

  • Colleluori G, Villareal DT. Aging, obesity, sarcopenia and the effect of diet and exercise intervention. Exp Gerontol. 2021 Nov;155:111561. doi: 10.1016/j.exger.2021.111561. Epub 2021 Sep 23.

    PubMed 34562568

  • Wilkinson DJ, Piasecki M, Atherton PJ. The age-related loss of skeletal muscle mass and function: Measurement and physiology of muscle fibre atrophy and muscle fibre loss in humans. Ageing Res Rev. 2018 Nov;47:123-132. doi: 10.1016/j.arr.2018.07.005. Epub 2018 Jul 23.

    PubMed 30048806

  • Wadden TA, Chao AM, Machineni S, Kushner R, Ard J, Srivastava G, Halpern B, Zhang S, Chen J, Bunck MC, Ahmad NN, Forrester T. Tirzepatide after intensive lifestyle intervention in adults with overweight or obesity: the SURMOUNT-3 phase 3 trial. Nat Med. 2023 Nov;29(11):2909-2918. doi: 10.1038/s41591-023-02597-w. Epub 2023 Oct 15.

    PubMed 37840095

  • Conte C, Hall KD, Klein S. Is Weight Loss-Induced Muscle Mass Loss Clinically Relevant? JAMA. 2024 Jul 2;332(1):9-10. doi: 10.1001/jama.2024.6586.

    PubMed 38829659

  • Frias JP, Davies MJ, Rosenstock J, Perez Manghi FC, Fernandez Lando L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515. doi: 10.1056/NEJMoa2107519. Epub 2021 Jun 25.

    PubMed 34170647

  • Kaneko S. Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes. touchREV Endocrinol. 2022 Jun;18(1):10-19. doi: 10.17925/EE.2022.18.1.10. Epub 2022 Jun 16.

    PubMed 35949358

  • Koyama AK, McKeever Bullard K, Xu F, Onufrak S, Jackson SL, Saelee R, Miyamoto Y, Pavkov ME. Prevalence of Cardiometabolic Diseases Among Racial and Ethnic Subgroups in Adults - Behavioral Risk Factor Surveillance System, United States, 2013-2021. MMWR Morb Mortal Wkly Rep. 2024 Jan 25;73(3):51-56. doi: 10.15585/mmwr.mm7303a1.

    PubMed 38271277

  • Prado CM, Phillips SM, Gonzalez MC, Heymsfield SB. Muscle matters: the effects of medically induced weight loss on skeletal muscle. Lancet Diabetes Endocrinol. 2024 Nov;12(11):785-787. doi: 10.1016/S2213-8587(24)00272-9. Epub 2024 Sep 9. No abstract available.

    PubMed 39265590

  • Neeland IJ, Linge J, Birkenfeld AL. Changes in lean body mass with glucagon-like peptide-1-based therapies and mitigation strategies. Diabetes Obes Metab. 2024 Sep;26 Suppl 4:16-27. doi: 10.1111/dom.15728. Epub 2024 Jun 27.

    PubMed 38937282

  • Larsson L, Degens H, Li M, Salviati L, Lee YI, Thompson W, Kirkland JL, Sandri M. Sarcopenia: Aging-Related Loss of Muscle Mass and Function. Physiol Rev. 2019 Jan 1;99(1):427-511. doi: 10.1152/physrev.00061.2017.

    PubMed 30427277

  • Eberly LA, Yang L, Essien UR, Eneanya ND, Julien HM, Luo J, Nathan AS, Khatana SAM, Dayoub EJ, Fanaroff AC, Giri J, Groeneveld PW, Adusumalli S. Racial, Ethnic, and Socioeconomic Inequities in Glucagon-Like Peptide-1 Receptor Agonist Use Among Patients With Diabetes in the US. JAMA Health Forum. 2021 Dec 17;2(12):e214182. doi: 10.1001/jamahealthforum.2021.4182. eCollection 2021 Dec.

    PubMed 35977298

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tirzepatide in people with Obesity Prevention and Sarcopenia in Elderly, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Suha Soni ((210)450-3333, BCRU@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Appendicular lean muscle mass (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06811324, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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