[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07220473":3,"trial-entities:NCT07220473":83,"trial-summary:NCT07220473":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":40,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":53,"locations":56,"central_contacts":75,"overall_officials":78,"references":81,"see_also_links":82},"NCT07220473","25-0169","Tirzepatide to Slow Biological Aging","The Moody Longevity Trial: Tirzepatide to Slow Biological Aging","RECRUITING","2028-01","2026-03","2026-03-24","2026-02-27","The University of Texas Medical Branch, Galveston","OTHER",false,"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.\n\nThe 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.\n\nSecondary and Exploratory Objectives\n\nAmong people 55-70 years of age with an indication for tirzepatide weight loss therapy, the is aim to:\n\n1. Estimate self-reported tolerability and acceptability of tirzepatide during the study period\n2. Estimate changes in BMI and weight over 24 W of tirzepatide therapy, and in off-drug follow-up, between W 24 and 36\n3. Estimate changes in physical function over 24 W of tirzepatide and, in off-drug follow-up, between W 24 and 36\n4. 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\n5. Estimate changes in other biological hallmarks\u002Fmarkers of aging\n6. Explore relationships between the above outcomes",[19,20],"Aging","LONGEVITY 1",[22,23,24],"DNA Methylation","Biological Clock Deceleration","GLP-1 Agonist","INTERVENTIONAL","PREVENTION",[28],"PHASE2",{"count":30,"type":31},90,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Zepbound","Auto injectors with a 2.5 mg dosage are given subcutaneously weekly.",[38],"Tirzepatide",[38],[41],{"measure":42,"description":43,"timeFrame":44},"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",[],"ALL","55 Years","70 Years",{"inclusion":50,"exclusion":51,"raw_text":52},[],[],"Inclusion Criteria:\n\n1. Age 55-70 years\n2. BMI ≥ 30 kg\u002Fm² or ≥ 27 kg\u002Fm² if also with ≥ 1 weight-related comorbidity\n3. If taking anti-inflammatory or blood-pressure-\u002Flipid-\u002Fglucose-lowering medications, no change in dose for ≥12 weeks prior to entry and no plans to dose escalate for the study duration\n4. Willing and able to provide written informed consent and undergo all required study procedures\n\nExclusion Criteria:\n\n1. BMI \\>35 kg\u002Fm²\n2. Uncontrolled or end-stage, comorbid, cardiometabolic disease, in the opinion of the site investigator\n3. Significant neurocognitive impairment, in the opinion of the site investigator\n4. 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)\n5. Use of insulin\n6. Plans to newly engage in formal, intensive physical activity or diet (such as ketogenic or very low carbohydrate) programs during the study period\n7. Active eating disorder\n8. 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 \\\u003C12 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\n9. Active, severe delayed gastric emptying\n10. Prior bariatric surgery or major gastric surgery or plans for weight reduction surgery while on study\n11. Known diabetic retinopathy\n12. Personal or first-degree relative history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2\n13. Untreated, poorly controlled or previously undiagnosed thyroid disease\n14. History of chronic pancreatitis\n15. History of suicidal attempts or active suicidal ideation, in the opinion of the site investigator\n16. Known allergy\u002Fsensitivity to GLP-1RA or GIPRA\n17. 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\n18. Any other medical condition that, in the opinion of the investigator, would place the subject at increased risk for participation.\n19. Pregnancy, nursing or plans for either during the study period",[54,55],"ADULT","OLDER_ADULT",[57],{"facility":58,"status":8,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":72},"University of Texas Medical Branch","Galveston","Texas","77555","United States",[64,69],{"name":65,"role":66,"phone":67,"email":68},"Lamonne Crutcher","CONTACT","409-772-1619","lmcrutch@utmb.edu",{"name":70,"role":71},"Thomas Blackwell, MD, FACP","PRINCIPAL_INVESTIGATOR",{"lat":73,"lon":74},29.30135,-94.7977,[76],{"name":65,"role":66,"phone":77,"email":68},"(409)772-1619",[79],{"name":70,"affiliation":80,"role":71},"University of Texas Medical Branch, Galveston",[],[],{"nct_id":4,"conditions":84,"biomarkers":85},[19],[],{"nct_id":4,"found":87,"summary":88,"prompt_version":97},true,{"design":89,"status":90,"heading":6,"summary":91,"follow_up":92,"word_count":93,"commitments":94,"compensation":95,"drugs_mentioned":96},"This is an interventional study with 90 participants, comparing Zepbound to no drug. Participants are randomly assigned to one of these groups.","completed","This study is looking at whether the drug Zepbound (tirzepatide) can affect how quickly people biologically age. We're inviting 90 adults, aged 55-70, who have a BMI of 30 or higher (or 27 with a weight-related health issue) to participate. Participants will receive weekly Zepbound injections or no drug for 24 weeks. While Zepbound is known for weight loss, this study focuses on its effects on aging markers, physical ability, and overall health. Success would mean seeing a significant change in biological age based on DNA methylation (a way to measure aging at a cellular level). The study status is currently unclear.","Participants will be followed for 12 weeks after stopping the drug, making the total study duration 36 weeks.",102,"Participants will receive weekly subcutaneous injections for 24 weeks. DNA methylation-based biological age will be measured at the start, and at weeks 4, 12, and 24.","Not stated in the trial record.",[35],"v2"]