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GLP1 Receptor Agonist

Semaglutide for Aging

Phase 4

Waitlist Available

Led By Tiffany M Cortes, MD

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have prediabetes or diabetes

Older than 65

Must not have

Have liver disease

Have heart disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks

Awards & highlights

No Placebo-Only Group

Drug Has Already Been Approved

Pivotal Trial

Summary

This trial will study the effects of semaglutide on people with diabetes or obesity, looking at physical function, body composition, and aging.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Semaglutide may cause digestive issues like nausea and constipation, risk of low blood sugar levels especially when combined with other diabetes medications, possible thyroid tumors including cancer (rare), pancreatitis, changes in vision due to diabetic retinopathy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have prediabetes or diabetes.

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I am older than 65.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have liver disease.

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I have heart disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 20 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~20 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lean body mass change

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Semaglutide and lifestyle interventionExperimental Treatment2 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 interventionActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lifestyle Counseling

2011

Completed Phase 2

~7440

Semaglutide Injectable Product

2024

Completed Phase 2

~120