NCT07104539

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress37%
Oct 2025May 2027

First Submitted

Initial submission to the registry

July 29, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 5, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 8, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

July 29, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

Weight lossGLP-1 agonistObesityLean massBody compositionStrength training

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    2-hour testing session in lab at baseline and 14 weeks.

Secondary Outcomes (1)

  • Muscle function

    500-meter timed walk in lab at baseline and 14 weeks

Study Arms (2)

Strenth Training

EXPERIMENTAL

Participants will undergo strength training 3 times per week for 14 weeks.

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.

Other: Wait first, then strength training

Interventions

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.

Strenth 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.

Waitlisted control

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24061, United States

RECRUITING

MeSH Terms

Conditions

Weight LossObesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kevin Davy

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kevin Davy

CONTACT

Elaina Marinik

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2025

First Posted

August 5, 2025

Study Start

October 8, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations