AgingPhase 2NCT07220473
Tirzepatide to Slow Biological Aging
A Phase 2 study testing Zepbound in people with Aging and LONGEVITY 1, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 to 70 years
- Conditions the study is for
- Aging, LONGEVITY 1
- What is being tested?
- Zepbound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2026to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Lamonne Crutcher, 409-772-1619, lmcrutch@utmb.edu
Thomas Blackwell, MD, FACP
About this study
Official title: The Moody Longevity Trial: Tirzepatide to Slow Biological Aging
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.
Read the 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 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:
- Estimate self-reported tolerability and acceptability of tirzepatide during the study period
- Estimate changes in BMI and weight over 24 W of tirzepatide therapy, and in off-drug follow-up, between W 24 and 36
- Estimate changes in physical function over 24 W of tirzepatide and, in off-drug follow-up, between W 24 and 36
- 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
- Estimate changes in other biological hallmarks/markers of aging
- Explore relationships between the above outcomes
- Conditions
- Aging, LONGEVITY 1
- Being tested
- Zepbound
- Keywords
- DNA Methylation, Biological Clock Deceleration, GLP-1 Agonist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZepboundDrug
Also called Tirzepatide
Auto injectors with a 2.5 mg dosage are given subcutaneously weekly.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Active comparator | Participants will receive Tirzepatide 2.5 mg weekly for 24 weeks, followed by a 12-week off-drug follow-up. Receives: Drug: Zepbound |
| Placebo | No intervention | Participants will be monitored for a total of 36 weeks without receiving medication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately before and after the study visit at Weeks 4, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2025
- Study start27 Feb 2026
- Primary completionNov 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Blackwell, MD, FACP, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07220473
- Sponsor's protocol ID
- 25-0169
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Moody Longevity Trial: Tirzepatide to Slow Biological Aging
- ClinicalTrials.gov ID
- NCT07220473
- Acronym / sponsor ID
- 25-0169
- Conditions
- Aging, LONGEVITY 1
- Keywords
- DNA Methylation, Biological Clock Deceleration, GLP-1 Agonist
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 27 Feb 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 24 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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:
- Estimate self-reported tolerability and acceptability of tirzepatide during the study period
- Estimate changes in BMI and weight over 24 W of tirzepatide therapy, and in off-drug follow-up, between W 24 and 36
- Estimate changes in physical function over 24 W of tirzepatide and, in off-drug follow-up, between W 24 and 36
- 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
- Estimate changes in other biological hallmarks/markers of aging
- Explore relationships between the above outcomes
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Active comparator | Drug: ZepboundParticipants will receive Tirzepatide 2.5 mg weekly for 24 weeks, followed by a 12-week off-drug follow-up. |
| Placebo | No intervention | –Participants will be monitored for a total of 36 weeks without receiving medication. |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZepboundAlso: TirzepatideAuto injectors with a 2.5 mg dosage are given subcutaneously weekly. | Drug | Tirzepatide |
Primary outcome
Change in DNA Methylation-Based Biological Age
Time frame: Immediately before and after the study visit at Weeks 4, 12, and 24
Change in biological age as measured by DNA methylation-based aging clocks (DNAmAge, DNAm PhenoAge, DNAm GrimAge, and DunedinPACE) following tirzepatide treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Blackwell, MD, FACP principal investigator
University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zepbound in people with Aging and LONGEVITY 1, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lamonne Crutcher ((409)772-1619, lmcrutch@utmb.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in DNA Methylation-Based Biological Age (time frame: Immediately before and after the study visit at Weeks 4, 12, and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.