Semaglutide for Aging

Overseen By Tiffany M Cortes, MD

Age: 65+

Sex: Any

Trial Phase: Phase 4

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Heart disease, Liver disease, Smoke

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: Unknown

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how semaglutide, a medication approved for diabetes and weight management, affects aging, physical function, and body composition. Participants will receive either semaglutide (an injectable product) with lifestyle counseling or just lifestyle counseling to assess the impact on their health. It suits individuals over 65 with prediabetes or diabetes, a BMI over 27, and who live independently. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment benefits more patients.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for these treatments?

Research has shown that semaglutide is usually well-tolerated. In studies with adults aged 65 and older, common side effects mostly involved the stomach, such as nausea or diarrhea, reported by about 44.6% to 73.8% of participants. However, some research suggested a possible link between semaglutide and a higher risk of developing age-related macular degeneration, which can affect vision. These findings are important to consider when deciding to join a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about semaglutide for aging because it offers a new approach by targeting metabolic pathways associated with aging. Unlike traditional treatments that focus mainly on symptom relief or lifestyle changes, semaglutide is a GLP-1 receptor agonist primarily used for diabetes and weight management. This drug could address the underlying metabolic issues that contribute to aging. Additionally, combining semaglutide with lifestyle interventions provides a dual-action approach, potentially enhancing overall effectiveness compared to lifestyle changes alone.

What is the effectiveness track record for semaglutide in managing weight and aging?

Research has shown that semaglutide, a drug already used for diabetes and weight loss, might also aid in aging. In this trial, one group of participants will receive semaglutide along with lifestyle counseling. Studies have found that semaglutide can lead to significant weight loss and make individuals biologically about 3 years younger, potentially enhancing their appearance and vitality. Other research suggests that semaglutide reduces more fat than muscle, helping to maintain strength. These benefits make semaglutide a promising option for improving physical function and overall health as people age. ^{1 6 7 8 9}

Who Is on the Research Team?

Tiffany M Cortes, MD

Principal Investigator

UT Health San Antonio

Are You a Good Fit for This Trial?

This trial is for older adults over 65 living on their own, with a BMI of 27 or higher and prediabetes or diabetes. It's not open to smokers or those with heart or liver disease.

Inclusion Criteria

I have prediabetes or diabetes.

I am older than 65.

I live on my own, not in a care facility.

Exclusion Criteria

I have heart disease.

I have liver disease.

You are a smoker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive semaglutide and lifestyle intervention for 20 weeks

20 weeks

Regular visits with a dietician

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle Counseling
• Semaglutide Injectable Product

Trial Overview

The study tests the effects of Semaglutide, an FDA-approved drug for blood sugar control and weight management, along with lifestyle counseling on physical function, body composition, and aging markers in older adults.

How Is the Trial Designed?

Group I: Semaglutide and lifestyle intervention Experimental Treatment 2 Interventions

Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program. They will also be given semaglutide for 20 weeks.

Group II: Lifestyle intervention Active Control 1 Intervention

Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12056300/

A pooled analysis of semaglutide in adults aged ≥ 65 years

Participants aged ≥ 65 years receiving semaglutide had an estimated weight loss of 3.8% at week 52 compared to 0.1% with placebo. DISCUSSION.

2.

mewburn.com

mewburn.com/news-insights/ozempic-and-the-anti-ageing-opportunity

Ozempic and the Anti-Ageing Opportunity

Participants receiving Ozempic weekly over 32 weeks exhibited an average biological age reduction of 3.1 years, as measured by epigenetic clocks ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2032183

Once-Weekly Semaglutide in Adults with Overweight or ...

Analyses from the DXA substudy suggested that semaglutide led to greater reduction in fat mass than lean body mass, a finding consistent with ...

4.

facebook.com

facebook.com/ScienceNaturePage/posts/ozempic-just-reversed-biological-aging-by-3-years-in-a-new-clinical-trialit-lite/1293736978873835/

Ozempic just reversed biological aging by 3 years in a new ...

Ozempic just reversed biological aging by 3 years in a new clinical trial. It literally made participants biologically younger, especially in ...

5.

news-medical.net

news-medical.net/news/20250804/HIV-trial-points-to-semaglutide-as-a-new-anti-aging-contender.aspx

HIV trial points to semaglutide as a new anti-aging contender

Study Results. Semaglutide significantly slowed epigenetic aging across multiple independent measures relative to placebo. In adjusted models, ...

6.

healthline.com

healthline.com/health-news/glp-1-drugs-age-related-macular-degeneration-risk

GLP-1 Drugs Linked to Age-Related Macular Degeneration ...

GLP-1 drugs are linked to a significantly higher risk of developing neovascular or “wet” age-related macular degeneration, according to new research.

7.

alz-journals.onlinelibrary.wiley.com

alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.14313

Associations of semaglutide with first‐time diagnosis of ...

Semaglutide was associated with significantly reduced risk for first-time AD diagnosis, most strongly compared with insulin.

8.

everydayhealth.com

everydayhealth.com/obesity/what-older-adults-need-to-know-before-taking-a-glp-1-like-ozempic/

GLP-1 Drugs for Older Adults - Weight Loss

Learn about the risks and benefits of GLP-1 medications like Ozempic for weight loss in older people and how this group can lose weight safely.

9.

medpagetoday.com

medpagetoday.com/ophthalmology/generalophthalmology/115919

Semaglutide Linked to Age-Related Macular ...

Patients taking GLP-1 agonists for type 2 diabetes for at least 6 months had an excess risk of nAMD compared with matched non-users over 3 years of follow-up.