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Tirzepatide to Slow Biological Aging Phase 2 90 Randomized Novel Treatment

Recruiting
Clinical Trial NCT07220473 is designed to study Prevention for Aging, LONGEVITY 1. It is a Phase 2 interventional study that is recruiting, having started on February 27, 2026, with plans to enroll 90 participants. Led by The University of Texas Medical Branch, Galveston, it is expected to complete by January 1, 2028. The latest data from ClinicalTrials.gov was last updated on March 24, 2026.
Brief Summary
This pilot clinical study aims to investigate the potential effects of tirzepatide on biological aging in older adults. In this novel study, 90 adults aged 55-70 years with an indication for tirzepatide weight-loss therapy will be randomized to receive either tirzepatide 2.5 mg subcutaneously (SC) weekly or no drug for 24 weeks, followed by 12 weeks off the drug. Since tirzepatide is already recognized as a highly ef...Show More
Detailed Description
Primary Objective To estimate the potential effect of tirzepatide on biological aging using epigenetic age (based on established DNA methylation-based clocks), among people 55-70 years of age with an indication for tirzepatide weight loss therapy.

The principal investigator (PI) will measure DNA methylation-based aging clocks (DNAmAge, DNAm PhenoAge, DNAm GrimAge and DunedinPACE) before and after a 24-W course of ti...

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Official Title

The Moody Longevity Trial: Tirzepatide to Slow Biological Aging

Conditions
AgingLONGEVITY 1
Other Study IDs
  • 25-0169
NCT ID Number
Start Date (Actual)
2026-02-27
Last Update Posted
2026-03-24
Completion Date (Estimated)
2028-01
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Keywords
DNA Methylation
Biological Clock Deceleration
GLP-1 Agonist
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorTirzepatide
Participants will receive Tirzepatide 2.5 mg weekly for 24 weeks, followed by a 12-week off-drug follow-up.
Zepbound
Auto injectors with a 2.5 mg dosage are given subcutaneously weekly.
No InterventionPlacebo
Participants will be monitored for a total of 36 weeks without receiving medication.
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in DNA Methylation-Based Biological Age
Change in biological age as measured by DNA methylation-based aging clocks (DNAmAge, DNAm PhenoAge, DNAm GrimAge, and DunedinPACE) following tirzepatide treatment.
Immediately before and after the study visit at Weeks 4, 12, and 24
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
55 Years
Eligible Sexes
All
  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

  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
The University of Texas Medical Branch, Galveston logoThe University of Texas Medical Branch, Galveston
Study Central Contact
Contact: Lamonne Crutcher, (409)772-1619, [email protected]
1 Study Locations in 1 Countries

Texas

University of Texas Medical Branch, Galveston, Texas, 77555, United States
Lamonne Crutcher, Contact, 409-772-1619, [email protected]
Thomas Blackwell, MD, FACP, Principal Investigator
Recruiting