Status:
NOT_YET_RECRUITING
Tirzepatide to Slow Biological Aging
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Aging
LONGEVITY 1
Eligibility:
All Genders
55-70 years
Phase:
PHASE2
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 tirzepati...
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 ...
Eligibility Criteria
Inclusion
- Age 55-70 years
- BMI ≥ 30 kg/m² or ≥ 27 kg/m² if also with ≥ 1 weight-related comorbidity
- 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
- Willing and able to provide written informed consent and undergo all required study procedures
Exclusion
- BMI \>35 kg/m²
- Uncontrolled or end-stage, comorbid, cardiometabolic disease, in the opinion of the site investigator
- Significant neurocognitive impairment, in the opinion of the site investigator
- 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)
- Use of insulin
- Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period
- Active eating disorder
- 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
- Active, severe delayed gastric emptying
- Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study
- Known diabetic retinopathy
- Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Untreated, poorly controlled or previously undiagnosed thyroid disease
- History of chronic pancreatitis
- History of suicidal attempts or active suicidal ideation, in the opinion of the site investigator
- Known allergy/sensitivity to GLP-1RA or GIPRA
- 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
- Any other medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.
- Pregnancy, nursing or plans for either during the study period
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2028
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT07220473
Start Date
December 1 2025
End Date
January 1 2028
Last Update
December 19 2025
Active Locations (1)
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1
University of Texas Medical Branch
Galveston, Texas, United States, 77555