Tirzepatide to Slow Biological Aging
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age55-70
SponsorThe University of Texas Medical Branch, Galveston
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Zepbound
DrugAuto injectors with a 2.5 mg dosage are given subcutaneously weekly.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: TirzepatideActive comparator 1 intervention
Group B: PlaceboNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 24Sponsors and contacts
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Source ClinicalTrials.gov