Tirzepatide to slow biological aging in older adults.

The Moody Longevity Trial: Tirzepatide to Slow Biological Aging

This will test whether weekly tirzepatide injections can slow biological aging in adults 55–70 who qualify for tirzepatide for weight loss.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Ages: 55 Years to 70 Years
• Sex: All
• Sponsor: The University of Texas Medical Branch, Galveston (other)
• Locations: 1 site (Galveston, Texas)
• Trial ID: NCT07220473 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 55–70 years old with BMI ≥30 kg/m² (or ≥27 kg/m² with a weight-related comorbidity) who are eligible for tirzepatide weight-loss therapy and can attend in-person visits are ideal candidates.

Not a fit: People with BMI over 35, uncontrolled or end-stage cardiometabolic disease, current insulin use, significant cognitive impairment, or plans for major new diet/exercise programs are unlikely to benefit or are excluded.

Why it matters

Potential benefit: If successful, tirzepatide could reduce epigenetic measures of biological aging and improve functional and biomarker indicators of healthier aging.

How similar studies have performed: Tirzepatide has demonstrated strong weight-loss and metabolic benefits in prior trials, but applying it to slow epigenetic clocks and biological aging is novel and largely untested.

Eligibility criteria

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 this trial is running

Galveston, Texas

• 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

Conditions: Aging, LONGEVITY 1, DNA Methylation, Biological Clock Deceleration, GLP-1 Agonist