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 effective weight-loss agent in this population, the primary focus will not be on measuring weight loss. Instead, the study will document the effects of tirzepatide on markers of aging, physical function, and overall health.
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 tirzepatide. The primary analysis will determine whether tirzepatide treatment leads to a statistically significant change in biological age as indicated by these clocks. The PI will specifically assess epigenetic age acceleration (epigenetic age minus chronological age) and the pace of aging metric. Secondary and Exploratory Objectives Among people 55-70 years of age with an indication for tirzepatide weight loss therapy, the is aim to: 1. Estimate self-reported tolerability and acceptability of tirzepatide during the study period 2. Estimate changes in BMI and weight over 24 W of tirzepatide therapy, and in off-drug follow-up, between W 24 and 36 3. Estimate changes in physical function over 24 W of tirzepatide and, in off-drug follow-up, between W 24 and 36 4. Estimate changes in inflammatory, aging and neurocognitive biomarker profiles over 24 W of tirzepatide therapy, and in off-drug follow-up, between W 24 and 36 5. Estimate changes in other biological hallmarks/markers of aging 6. Explore relationships between the above outcomes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
90
Auto injectors with a 2.5 mg dosage are given subcutaneously weekly.
University of Texas Medical Branch
Galveston, Texas, United States
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.
Time frame: Immediately before and after the study visit at Weeks 4, 12, and 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.