Tirzepatide for Aging

Overseen By Charles Cass

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: The University of Texas Medical Branch, Galveston

Must not be taking: Insulin, Obesity medications

Disqualifiers: BMI >35, Cardiometabolic disease, Neurocognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 28

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how tirzepatide, a medication known for aiding weight loss, might affect aging markers in individuals aged 55 to 70 who meet specific weight criteria. Participants will either receive the medication or be monitored without it for 24 weeks, followed by a 12-week observation period. The trial aims to determine if tirzepatide can improve signs of aging, physical function, and overall health beyond weight loss. Individuals with a BMI of 30 or higher (or 27 with related health issues) who haven't recently changed certain medications might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify that you must stop taking your current medications, but you cannot change the dose of any anti-inflammatory, blood-pressure, lipid, or glucose-lowering medications for at least 12 weeks before starting the trial and during the study. Also, you cannot use medications for obesity or those likely to cause significant weight changes during the study.

Is there any evidence suggesting that tirzepatide is likely to be safe for humans?

Research has shown that tirzepatide is generally safe for older adults. In one study, 30.1% of participants were 65 or older, indicating that tirzepatide has been tested in people similar in age to those in this trial. Another study found that tirzepatide is safe and effective for people of different ages and body weights, including older adults.

Although some real-world reports lack complete details, previous research supports tirzepatide as a relatively safe option. Overall, these findings suggest that tirzepatide has a good safety record, especially for older adults. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for aging?

Most treatments for aging focus on lifestyle changes, supplements, or skincare products. But tirzepatide works differently, targeting metabolic pathways to potentially slow down the aging process. Researchers are excited about tirzepatide because it’s originally used for managing diabetes and obesity, leveraging its effects on metabolism to address aspects of aging. Its once-weekly injection offers a convenient delivery method, potentially improving adherence compared to daily treatments. This novel approach could open up new possibilities for how we think about treating aging itself.

What evidence suggests that tirzepatide might be an effective treatment for aging?

Research has shown that tirzepatide effectively aids weight loss and improves health. In this trial, participants will receive either tirzepatide or a placebo. Studies have found that older adults using tirzepatide lost significant weight, with some losing up to 20.9% of their body weight. This weight loss can help control blood sugar levels and provide overall health benefits, such as lowering the risk of diabetes and heart problems. Additionally, tirzepatide has improved muscle mass, strength, and blood vessel health. These findings suggest that tirzepatide could positively affect aging and physical health in older adults. ^{2 6 7 8 9}

Who Is on the Research Team?

Thomas Blackwell, MD, FACP

Principal Investigator

University of Texas Medical Branch, Galveston

Are You a Good Fit for This Trial?

This trial is for older adults aged 55-70 who could benefit from weight-loss therapy with tirzepatide. Participants must be suitable for tirzepatide treatment, but the specific inclusion and exclusion criteria are not provided in the details given.

Inclusion Criteria

Willing and able to provide written informed consent and undergo all required study procedures

I am between 55 and 70 years old.

My BMI is 30 or higher, or it's 27 or higher with a weight-related health issue.

Exclusion Criteria

Significant neurocognitive impairment, in the opinion of the site investigator

Active eating disorder

History of suicidal attempts or active suicidal ideation, in the opinion of the site investigator

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Tirzepatide 2.5 mg weekly for 24 weeks

24 weeks

Visits at Weeks 4, 12, and 24

Follow-up

Participants are monitored off-drug for changes in biological markers and physical function

12 weeks

Monitoring between Weeks 24 and 36

What Are the Treatments Tested in This Trial?

Interventions

• Tirzepatide

Trial Overview The study tests if tirzepatide can affect biological aging markers in those already indicated for its use as a weight-loss drug. It's a randomized trial where half get the drug weekly for 24 weeks and then stop for 12 weeks, while others receive no drug.

How Is the Trial Designed?

Group I: Tirzepatide Active Control 1 Intervention

Participants will receive Tirzepatide 2.5 mg weekly for 24 weeks, followed by a 12-week off-drug follow-up.

Group II: Placebo Active Control 1 Intervention

Participants will be monitored for a total of 36 weeks without receiving medication.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11925828/

Tirzepatide for Older Adults with Type 2 Diabetes and Without ... Older participants exhibited a clinically meaningful decrease in HbA1c and dose-dependent weight reduction across all tirzepatide doses (5, 10, ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1751991825000816

The promise of tirzepatide: A narrative review of metabolic ... Tirzepatide administration for 72 weeks elicited significant weight reduction ranging from 5 % to 20.9 % across different trials in a dose-dependent manner.

3. jamanetwork.com jamanetwork.com/journals/jama-health-forum/fullarticle/2831205

Lifetime Health Effects and Cost-Effectiveness of ... Tirzepatide and semaglutide were found to generate greater lifetime health gains by preventing diabetes, cardiovascular complications, and death.

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2416394

Tirzepatide as Compared with Semaglutide for ... Treatment with tirzepatide was superior to treatment with semaglutide with respect to reduction in body weight and waist circumference at week 72.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06811324

NCT06811324 | Effects of Tirzepatide on Muscle and ... This study is a pilot, single-arm, open-label clinical trial to evaluate the effects of Tirzepatide on muscle mass, strength, and vascular health among older ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK585056/

Tirzepatide - StatPearls - NCBI Bookshelf Older patients: For older patients, in a collective analysis of 7 clinical trials, 30.1% were aged 65 or older, with 4.1% aged 75 or older.

7. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.14952

Safety and efficacy analyses across age and body mass index ... This post hoc analysis showed that once-weekly tirzepatide had a similar safety and efficacy profile across BMI and age subgroups in East Asian participants.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12469573/

Real-World Safety Concerns of Tirzepatide A large number of reports were missing key demographic and clinical information, as follows: age was unknown in 35.9%, sex was not reported in ...

9. link.springer.com link.springer.com/article/10.1007/s13300-025-01711-0

A Post Hoc Analysis of the SURPASS Clinical Trials Tirzepatide may be an effective treatment for older adults without obesity, and in this post hoc analysis, it was associated with clinically relevant HbA1c ...