NCT05786521

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2024

Completed
12 months until next milestone

Results Posted

Study results publicly available

May 4, 2025

Completed
Last Updated

May 4, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

March 2, 2023

Results QC Date

April 2, 2025

Last Update Submit

April 22, 2025

Conditions

AgingDiabetes Mellitus, Type 2PreDiabetesOverweight and Obesity

Outcome Measures

Primary Outcomes (1)

  • Lean Body Mass Change

    Determine if there is any change in lean body mass

    Baseline to 20 weeks

Study Arms (2)

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.

Drug: Semaglutide Injectable ProductBehavioral: 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

Behavioral: Lifestyle Counseling

Interventions

Semaglutide Injectable ProductDRUG

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
Semaglutide and lifestyle intervention
Lifestyle CounselingBEHAVIORAL

Lifestyle Counseling will be provided throughout study intervention

Lifestyle interventionSemaglutide and lifestyle intervention

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Have heart disease
  • Have liver disease
  • Smoke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • 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.

    PMID: 39269759DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Prediabetic StateOverweightObesity

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
TIffany M Cortes, MD
Organization
University of Texas Health Science Center San Antonio
cortest@uthscsa.edu
210-450-3333

Study Officials

  • Tiffany M Cortes, MD

    UT Health San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 2, 2023

First Posted

March 27, 2023

Study Start

April 1, 2023

Primary Completion

May 20, 2024

Study Completion

May 20, 2024

Last Updated

May 4, 2025

Results First Posted

May 4, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)