Tirzepatide to slow biological aging in older adults.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized pilot will enroll 90 adults aged 55–70 who meet clinical criteria for tirzepatide weight-loss therapy and randomize them to weekly tirzepatide 2.5 mg subcutaneously for 24 weeks or to no drug, followed by 12 weeks off drug. The primary outcome is change in biological age measured by DNA methylation-based clocks (DNAmAge, PhenoAge, GrimAge, and DunedinPACE) before and after treatment. Secondary and exploratory outcomes include tolerability, changes in BMI and weight, physical function, and inflammatory and neurocognitive biomarkers. All study visits are conducted at the University of Texas Medical Branch in Galveston, Texas.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 55-70 years
2. BMI ≥ 30 kg/m² or ≥ 27 kg/m² if also with ≥ 1 weight-related comorbidity
3. If taking anti-inflammatory or blood-pressure-/lipid-/glucose-lowering medications, no change in dose for ≥12 weeks prior to entry and no plans to dose escalate for the study duration
4. Willing and able to provide written informed consent and undergo all required study procedures

Exclusion Criteria:

1. BMI \>35 kg/m²
2. Uncontrolled or end-stage, comorbid, cardiometabolic disease, in the opinion of the site investigator
3. Significant neurocognitive impairment, in the opinion of the site investigator
4. Current or planned use of medications for the treatment of obesity, or medications likely to cause significant changes in weight, during the study period (see prohibited medications, section 6.0)
5. Use of insulin
6. Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period
7. Active eating disorder
8. Use of human growth hormone, tesamorelin, supraphysiologic testosterone or estradiol (stable doses for contraception, hypogonadism or other indications for exogenous sex steroid replacement therapy permitted) or anabolic steroids \<12 W prior to entry, unless on a stable dose for \>24 W prior to entry, or plans to start any of these medications while on study
9. Active, severe delayed gastric emptying
10. Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study
11. Known diabetic retinopathy
12. Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
13. Untreated, poorly controlled or previously undiagnosed thyroid disease
14. History of chronic pancreatitis
15. History of suicidal attempts or active suicidal ideation, in the opinion of the site investigator
16. Known allergy/sensitivity to GLP-1RA or GIPRA
17. Use or planned use of any immunomodulatory therapy or investigational therapy during the study period or use of an investigational therapy within 30 days of entry
18. Any other medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
19. Pregnancy, nursing or plans for either during the study period

Where it's running

• University of Texas Medical Branch
  Galveston, Texas, United States Recruiting

Study contacts

• Principal investigator: Thomas Blackwell, MD, FACP — University of Texas Medical Branch, Galveston
• Study coordinator: Lamonne Crutcher
• Email: lmcrutch@utmb.edu
• Phone: (409)772-1619

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.