LongevityPhase 2NCT07906041
Tirzepatide and Organ-specific Biological Aging
A Phase 2 study testing Tirzepatide in people with Longevity and Preventive Medicine, run by Atria Research and Global Health Institute (ARGHI) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate blood-based measures of organ-specific biological age, with a particular focus on the brain, and to investigate their relationship with established clinical indicators of health and their response to treatment with tirzepatide. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Longevity, Preventive Medicine, Biological Ageing
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Sep 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Stable medical status (neurological, cardiovascular, and immuno inflammatory)
- Adults age 50-75 years
- Eligible and waitlisted for brain health program onboarding
- Willingness to undergo serial blood sampling, wearable monitoring, and MRI
- Willingness to be assigned to the interventional trial or non-interventional trial
- Willingness to accept tirzepatide treatment (interventional arm)
Who cannot join
- Major neurodegenerative disease (e.g., dementia)
- Clinical and correlative imaging history of ischemic or hemorrhagic stroke
- History of myocardial infarction (ACS) or heart failure
- Significant inflammatory, autoimmune, or infectious disease or current treatments/interventions likely to distort proteomic aging measures
- Contraindications to MRI
- Currently taking tirzepatide
Show all 19Show fewer
- Pre-existing indications for tirzepatide (e.g., Type 2 diabetes, obesity, or obstructive sleep apnea)
- BMI less than 20.0
- Known contraindication to tirzepatide, including a personal or family history of medullary thyroid carcinoma, Multiple Endocrine Neoplasia syndrome type 2, or known serious hypersensitivity to tirzepatide
- Active pancreatitis or history of recurrent pancreatitis
- Severe gastroparesis
- Clinically significant renal, hepatic, glycemic, or other laboratory abnormality that could increase the risk associated with tirzepatide treatment
- Current use of insulin or insulin secretagogues (e.g., sulfonylureas)
- Use of another incretin-based therapy unless discontinued for at least 35 days prior to enrollment
- History of clinically significant intolerance to tirzepatide or another incretin-based therapy
- Any other condition, illness, or medication that, in the judgment of the clinical investigative team, would make the individual an unsuitable candidate for tirzepatide or participation in this trial
- Contraindication to a wearable ring
- Pregnancy or lactation
- Prisoners
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
Atria Research and Global Health Institute
New York, New York, 10022
About this study
Official title: Tirzepatide and Organ-Specific Biological Aging: A Parallel-Design Feasibility Study Using Proteomic Organ Clocks in a Preventive Brain Health Cohort
The purpose of this study is to evaluate blood-based measures of organ-specific biological age, with a particular focus on the brain, and to investigate their relationship with established clinical indicators of health and their response to treatment with tirzepatide.
- Conditions
- Longevity, Preventive Medicine, Biological Ageing
- Being tested
- Tirzepatide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Tirzepatide, a dual GLP-1/GIP receptor agonist, is administered by subcutaneous injection once weekly for 6 months. The starting dose is 2.5 mg weekly, with optional dose escalation in 2.5 mg increments at intervals of at least 4 weeks, based on tolerability and investigator assessment, to a maximum of 10 mg weekly.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Participants continue routine Brain Health program care without receiving tirzepatide or placebo through the study. Participants complete study assessments at baseline, Month 3, and Month 6. |
| Tirzepatide | Experimental | Participants receive tirzepatide by subcutaneous injection once weekly for 6 months, starting at 2.5 mg. The dose may be increased at intervals of at least 4 weeks, based on tolerability and investigator assessment, to a maximum of 10 mg weekly. Participants continue routine Brain Health program care and complete study assessments at baseline, Month 3, and Month 6. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proteomic Brain Age Gap From Baseline to Month 6
Change from baseline to Month 6 in proteomic brain age gap, measured in years. Brain biological age is estimated using Vero Bioscience's organ aging platform, which applies machine learning models to blood protein measurements to estimate organ-specific biological age. Brain age gap is defined as the difference between this estimated brain biological age and the participant's chronological age.
Measured: From baseline to Month 6
Secondary outcomes (1)
Between-Group Difference in Change in Proteomic Brain Age Gap From Baseline to Month 6
Difference between the tirzepatide-treated and observation groups in the change in proteomic brain age gap from baseline to Month 6, measured in years.
Measured: From baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LongevityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atria Research and Global Health Institute (ARGHI)
- Sponsor type
- University, hospital or other
- Collaborators
- Vero Bioscience, Inc.
- Responsible party
- Principal investigator, Bart Demaerschalk, Atria Research and Global Health Institute (ARGHI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07906041
- Sponsor's protocol ID
- 26-02-569-2231
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tirzepatide and Organ-Specific Biological Aging: A Parallel-Design Feasibility Study Using Proteomic Organ Clocks in a Preventive Brain Health Cohort
- ClinicalTrials.gov ID
- NCT07906041
- Acronym / sponsor ID
- 26-02-569-2231
- Conditions
- Longevity, Preventive Medicine, Biological Ageing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Atria Research and Global Health Institute (ARGHI)University, hospital or other
- Collaborators
- Vero Bioscience, Inc.
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 30 Oct 2026 (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.
The purpose of this study is to evaluate blood-based measures of organ-specific biological age, with a particular focus on the brain, and to investigate their relationship with established clinical indicators of health and their response to treatment with tirzepatide.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Participants continue routine Brain Health program care without receiving tirzepatide or placebo through the study. Participants complete study assessments at baseline, Month 3, and Month 6. |
| Tirzepatide | Experimental | Drug: TirzepatideParticipants receive tirzepatide by subcutaneous injection once weekly for 6 months, starting at 2.5 mg. The dose may be increased at intervals of at least 4 weeks, based on tolerability and investigator assessment, to a maximum of 10 mg weekly. Participants continue routine Brain Health program care and complete study assessments at baseline, Month 3, and Month 6. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Stable medical status (neurological, cardiovascular, and immuno inflammatory)
- Adults age 50-75 years
- Eligible and waitlisted for brain health program onboarding
- Willingness to undergo serial blood sampling, wearable monitoring, and MRI
- Willingness to be assigned to the interventional trial or non-interventional trial
Key exclusion criteria (19 listed)
- Major neurodegenerative disease (e.g., dementia)
- Clinical and correlative imaging history of ischemic or hemorrhagic stroke
- History of myocardial infarction (ACS) or heart failure
- Significant inflammatory, autoimmune, or infectious disease or current treatments/interventions likely to distort proteomic aging measures
- Contraindications to MRI
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 |
|---|---|---|
| TirzepatideTirzepatide, a dual GLP-1/GIP receptor agonist, is administered by subcutaneous injection once weekly for 6 months. The starting dose is 2.5 mg weekly, with optional dose escalation in 2.5 mg increments at intervals of at least 4 weeks, based on tolerability and investigator assessment, to a maximum of 10 mg weekly. | Drug | Tirzepatide |
Primary outcome
Change in Proteomic Brain Age Gap From Baseline to Month 6
Time frame: From baseline to Month 6
Change from baseline to Month 6 in proteomic brain age gap, measured in years. Brain biological age is estimated using Vero Bioscience's organ aging platform, which applies machine learning models to blood protein measurements to estimate organ-specific biological age. Brain age gap is defined as the difference between this estimated brain biological age and the participant's chronological age.
1 secondary outcome
Between-Group Difference in Change in Proteomic Brain Age Gap From Baseline to Month 6
Time frame: From baseline to Month 6
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 2 Nov 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Tirzepatide in people with Longevity and Preventive Medicine, run by Atria Research and Global Health Institute (ARGHI) 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 6 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: enrolling by invitation, as of the sponsor's last update on 2 Nov 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Proteomic Brain Age Gap From Baseline to Month 6 (time frame: From baseline to Month 6). 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 2 Nov 2026.