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CompletedNCT05786521Updated May 4, 2025Results posted

Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults

A Phase 4 interventional study of Semaglutide Injectable Product and Lifestyle Counseling in Aging, Diabetes Mellitus, Type 2 and PreDiabetes, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 65 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-04.

Sponsored by The University of Texas Health Science Center at San Antonio · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
65 Years to 90 Years
Sex
All
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Study summary

Semaglutide is a medication approved by the US Food and Drug Administration (FDA) as an antihyperglycemic (a drug that reduces glucoses in those with diabetes) and for weight management. This new study will help find out what effects, semaglutide has on people who take the drug and the drug's effect on physical function, body composition, and aging.

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Conditions studied

  • Aging
  • Diabetes Mellitus, Type 2
  • PreDiabetes
  • Overweight and Obesity
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In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 20 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.

Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Older than 65
  • Have prediabetes or diabetes
  • BMI ≥ 27.0 kg/m2
  • Living independently (not in assisted living or nursing home)

Exclusion criteria

Exclusion Criteria:

  • Have heart disease
  • Have liver disease
  • Smoke
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Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Semaglutide and lifestyle intervention

    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.

    Drug: Semaglutide Injectable Product · Behavioral: Lifestyle Counseling

  • Active comparator
    Lifestyle intervention

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

    Behavioral: Lifestyle Counseling

Interventions

  • DrugSemaglutide Injectable Product

    Semaglutide will be started at 0.25mg once a week for 4 weeks followed by 0.5mg once weekly for 4 weeks followed by 1.0mg once a week for 12 weeks.

    Also known as: Semaglutide and Lifestyle Counseling

  • BehavioralLifestyle Counseling

    Lifestyle Counseling will be provided throughout study intervention

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What researchers measure

Primary outcomes

  1. Lean Body Mass Change

    Determine if there is any change in lean body mass

    Time frame: Baseline to 20 weeks

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Results

Posted May 4, 2025

Participant flow

Participant flow — Overall Study
MilestoneSemaglutide and Lifestyle InterventionLifestyle Intervention
Started1010
Completed1010
Not completed00

Outcome measures

PrimaryLean Body Mass Change

Determine if there is any change in lean body mass

Time frame:
Baseline to 20 weeks
Reported as:
Mean · g
Lean Body Mass Change
gSemaglutide and Lifestyle InterventionLifestyle Intervention
Lean Body Mass Change-1730.6 (-3063 to -398)-421 (-1745 to 911)

Adverse events

Collected over 20 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Semaglutide and Lifestyle Intervention0/10 (0%)0/10 (0%)6/10 (60%)
Lifestyle Intervention0/10 (0%)0/10 (0%)1/10 (10%)
Most frequent other events
Most frequent other events
EventSemaglutide and Lifestyle InterventionLifestyle Intervention
Abdominal painGastrointestinal disorders6/101/10

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Semaglutide and Lifestyle InterventionLifestyle InterventionTotal
<=18 years000
Between 18 and 65 years000
>=65 years101020
Age, Continuous
Age, Continuous(years)Semaglutide and Lifestyle InterventionLifestyle InterventionTotal
Mean71.9 ± 4.8573.4 ± 4.9872.65 ± 4.85
Sex: Female, Male
Sex: Female, Male(Participants)Semaglutide and Lifestyle InterventionLifestyle InterventionTotal
Female5510
Male5510
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Semaglutide and Lifestyle InterventionLifestyle InterventionTotal
Hispanic or Latino549
Not Hispanic or Latino5611
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)Semaglutide and Lifestyle InterventionLifestyle InterventionTotal
United States101020
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Study locations

1 site
  • UT Health San Antonio
    San Antonio, Texas 78229, United States
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References and documents

Study documents

  • Protocol and statistical analysis plan · Mar 23, 2023
  • Informed consent form · Aug 30, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05786521
Lead sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute on Aging (NIA)
Responsible party
Tiffany Cortes (Assistant Professor, The University of Texas Health Science Center at San Antonio) — Principal investigator
First posted
Mar 27, 2023
Start date
Apr 1, 2023
Primary completion
May 20, 2024
Completion
May 20, 2024
Results posted
May 4, 2025
Last update
May 4, 2025

Study contacts

Tiffany M Cortes, MD
principal investigator · UT Health San Antonio

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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