Muscle MassSTRONG-GLPNCT07104539
Strength Training Response of Muscle in GLP-1 Users
A study testing Strength Training and Wait first, then strength training in people with Muscle Mass, run by Virginia Polytechnic Institute and State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass
- What is being tested?
- Strength Training and Wait first, then strength training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <50
- Weight >300 lb
- Osteoporosis
- Active metabolic, neoplastic, or cardiovascular disease
- Unable or unwilling to provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Virginia Tech
Blacksburg, Virginia, 24061
About this study
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.
- Conditions
- Muscle Mass
- Being tested
- Strength Training, Wait first, then strength training
- Keywords
- Weight loss, GLP-1 agonist, Obesity, Lean mass, Body composition, Strength training
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength TrainingBehavioural
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.
Wait first, then strength trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Strenth Training | Experimental | Participants will undergo strength training 3 times per week for 14 weeks. Receives: Behavioral: Strength Training |
| Waitlisted control | Other | 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. Receives: Other: Wait first, then strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass by d3-creatine dilution
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.
Measured: 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
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.
Measured: 2-hour testing session in lab at baseline and 14 weeks.
Secondary outcomes (1)
Muscle function
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.
Measured: 500-meter timed walk in lab at baseline and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start8 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle MassStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Polytechnic Institute and State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Davy, Virginia Polytechnic Institute and State University
- Investigators
- Kevin Davy, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07104539
- Sponsor's protocol ID
- 25-707
- Acronym
- STRONG-GLP
- Status last verified
- Jan 2026
- First submitted
- 29 Jul 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength Training Response of Muscle in GLP-1 Users
- ClinicalTrials.gov ID
- NCT07104539
- Acronym / sponsor ID
- STRONG-GLP / 25-707
- Conditions
- Muscle Mass
- Keywords
- Weight loss, GLP-1 agonist, Obesity, Lean mass, Body composition, Strength training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 5 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strenth Training | Experimental | Behavioral: Strength TrainingParticipants will undergo strength training 3 times per week for 14 weeks. |
| Waitlisted control | Other | Other: Wait first, then strength trainingParticipants 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Age <50
- Weight >300 lb
- Osteoporosis
- Active metabolic, neoplastic, or cardiovascular disease
- Unable or unwilling to provide consent
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 |
|---|---|---|
| Strength TrainingParticipants 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. | Behavioural | Strenth Training |
| Wait first, then strength trainingParticipants 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. | Other | Waitlisted control |
Primary outcome
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.
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.
1 secondary outcome
Muscle function
Time frame: 500-meter timed walk in lab at baseline and 14 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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.
Kevin Davy principal investigator
Virginia Polytechnic Institute and State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength Training and Wait first, then strength training in people with Muscle Mass, run by Virginia Polytechnic Institute and State University 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 5 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kevin Davy (540-231-3487, kdavy@vt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.