AgingPhase 4NCT05786521
Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Markers of Aging in Older Adults
A Phase 4 study testing Semaglutide Injectable Product and Lifestyle Counseling in people with Aging and Diabetes Mellitus, Type 2, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Aging, Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- Semaglutide Injectable Product and Lifestyle Counseling
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2023to 20 May 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Older than 65
- Have prediabetes or diabetes
- BMI ≥ 27.0 kg/m2
- Living independently (not in assisted living or nursing home)
Who cannot join
- Have heart disease
- Have liver disease
- Smoke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Biomarkers of Aging in Older Overweight/Obese Adults With Insulin Resistance
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.
- Conditions
- Aging, Diabetes Mellitus, Type 2, PreDiabetes, Overweight and Obesity
- Being tested
- Semaglutide Injectable Product, Lifestyle Counseling
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Injectable ProductDrug
Also called Semaglutide and Lifestyle Counseling
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.
Lifestyle CounselingBehavioural
Lifestyle Counseling will be provided throughout study intervention
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide and lifestyle intervention | Experimental | 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. Receives: Drug: Semaglutide Injectable Product; Behavioral: Lifestyle Counseling |
| Lifestyle intervention | Active comparator | Participants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program Receives: Behavioral: Lifestyle Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean Body Mass Change
Determine if there is any change in lean body mass
Measured: Baseline to 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start1 Apr 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Tiffany Cortes, The University of Texas Health Science Center at San Antonio
- Investigators
- Tiffany M Cortes, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786521
- Sponsor's protocol ID
- 20220256HU
- Other IDs
- 5P30AG044271-08
- Status last verified
- Apr 2025
- First submitted
- 2 Mar 2023
- Last updated
- 4 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cortes TM, Vasquez L, Serra MC, Robbins R, Stepanenko A, Brown K, Barrus H, Campos A, Espinoza SE, Musi N. Effect of Semaglutide on Physical Function, Body Composition, and Biomarkers of Aging in Older Adults With Overweight and Insulin Resistance: Protocol for an Open-Labeled Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 13;13:e62667. doi: 10.2196/62667.
PubMed 39269759
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of GLP1 Receptor Agonists on Physical Function, Body Composition, and Biomarkers of Aging in Older Overweight/Obese Adults With Insulin Resistance
- ClinicalTrials.gov ID
- NCT05786521
- Acronym / sponsor ID
- 20220256HU
- Conditions
- Aging, Diabetes Mellitus, Type 2, PreDiabetes, Overweight and Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 27 Mar 2023 (actual)
- Results
- Posted 4 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide and lifestyle intervention | Experimental | Drug: Semaglutide Injectable Product, Behavioral: Lifestyle CounselingParticipants 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. |
| Lifestyle intervention | Active comparator | Behavioral: Lifestyle CounselingParticipants will meet with a dietician throughout the study to discuss lifestyle counseling based on recommendation in the diabetes prevention program |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Older than 65
- Have prediabetes or diabetes
- BMI ≥ 27.0 kg/m2
- Living independently (not in assisted living or nursing home)
Key exclusion criteria (3 listed)
- Have heart disease
- Have liver disease
- Smoke
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 |
|---|---|---|
| Semaglutide Injectable ProductAlso: Semaglutide and Lifestyle CounselingSemaglutide 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. | Drug | Semaglutide and lifestyle intervention |
| Lifestyle CounselingLifestyle Counseling will be provided throughout study intervention | Behavioural | Lifestyle intervention, Semaglutide and lifestyle intervention |
Primary outcome
Lean Body Mass Change
Time frame: Baseline to 20 weeks
Determine if there is any change in lean body mass
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39269759Cortes TM, Vasquez L, Serra MC, Robbins R, Stepanenko A, Brown K, Barrus H, Campos A, Espinoza SE, Musi N. Effect of Semaglutide on Physical Function, Body Composition, and Biomarkers of Aging in Older Adults With Overweight and Insulin Resistance: Protocol for an Open-Labeled Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 13;13:e62667. doi: 10.2196/62667.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Tiffany M Cortes, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide Injectable Product and Lifestyle Counseling in people with Aging and Diabetes Mellitus, Type 2, run by The University of Texas Health Science Center at San Antonio 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 4 May 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Lean Body Mass Change (time frame: Baseline to 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05786521, which also lists 1 linked publication.
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 4 May 2025.