Strength Training Response of Muscle in GLP-1 Users (STRONG-GLP)

January 16, 2026 updated by: Kevin Davy, Virginia Polytechnic Institute and State University
GLP-1 medication is being prescribed for weight loss. However, GLP-1 medication may adversely affect muscle mass and muscle function. Moreover, any loss of muscle mass or muscle function with GLP-1 treatment may impair balance and increase fall risk. This is a particular concern among older adults already susceptible to the common muscle strength and muscle function loss with age, yet there is little evidence among this population. This study will address a gap in knowledge regarding the effects of GLP-1 treatment on muscle mass, muscle function, and balance/fall risk among adults age 50 and older.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Kevin Davy
  • Phone Number: 540-231-3487
  • Email: kdavy@vt.edu

Study Contact Backup

Study Locations

  • United States
    • Virginia
      • Blacksburg, Virginia, United States, 24061
        • Recruiting
        • Virginia Tech

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age, 50y+
  • Be taking GLP-1 medicine (Weygovy or Zepbound) for 1 month or less
  • Weight <300 lb
  • Pass a health and exercise readiness screening

Exclusion Criteria:

  • Age <50
  • Weight >300 lb
  • Osteoporosis
  • Active metabolic, neoplastic, or cardiovascular disease
  • Unable or unwilling to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Strenth Training
Participants will undergo strength training 3 times per week for 14 weeks.
Behavioral: Strength Training
Participants taking a GLP-1 will undergo a 14-week strength training regimen to determine changes in muscle mass. They will perform a series of resistance training exercises supervised by a personal trainer on 3 days per week.
Other: Waitlisted control
Participants will have no strength training intervention for 14 weeks. Participants will be offered the same 14-week strength training program after the initial 14 weeks.
Other: Wait first, then strength training
Participants will be waitlisted and receive the 14-week strength training intervention at the end of the waitlist period. During the waitlist period, participants will get no intervention and then be offered the strength training intervention after the first 14 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Muscle mass by d3-creatine dilution
Time Frame: Water containing creatine isotope consumed in lab; Urine sample collection on Day 0 and Day 3 at baseline and 14 weeks.
Participants will collect a urine sample prior to be provided a creatine capsule containing 30 milligrams of a naturally-occurring creatine isotope. A glass of water will be provided to wash it down. Participants will be asked to return ~3 days later to provide another urine sample. Urine samples will be analyzed at an off-site laboratory to determine changes in d3-creatine excretion before and after the 14-week strength training intervention.
Water containing creatine isotope consumed in lab; Urine sample collection on Day 0 and Day 3 at baseline and 14 weeks.
Balance testing - Percentage of failed recoveries
Time Frame: 2-hour testing session in lab at baseline and 14 weeks.
Participants will stand on the treadmill with the belt stationary. The belt will then suddenly change to a speed specified by the investigator, and the participant will attempt to step to maintain their balance and establish a stable gait. In addition to the treadmill itself, this system includes an integrated fall arrest harness that is anchored to an overhead gantry that is fixed to the treadmill. This harness prevents any body part but the feet from impacting the treadmill in the event that the participant is unable to maintain their balance after a sudden change in speed.
2-hour testing session in lab at baseline and 14 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle function
Time Frame: 500-meter timed walk in lab at baseline and 14 weeks
Participants will walk 500 meters down and back along a hallway at a self-selected pace. The walk will be measured, supervised, and timed by lab personnel.
500-meter timed walk in lab at baseline and 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Virginia Polytechnic Institute and State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kevin Davy, Virginia Polytechnic Institute and State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25-707

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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