GLP - 1Phase 4NCT07554417
Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment Evaluates Whether a 12-week Exercise and Individualized Nutrition Program Can Reduce Muscle and Bone Loss and Improve Strength, Fitness, and Function in Obese Adults on GLP-1
A Phase 4 study testing Semaglutide, Dietary Counseling and Exercise in people with GLP - 1 and Obesity & Overweight, run by William Marsh Rice University at 1 site in United States.
Trial summary
Obesity remains a critical public health challenge and is associated with increased rates of morbidity, mortality, and chronic disease worldwide. In recent years, glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have emerged as highly effective pharmacological treatments for obesity, producing… Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- GLP - 1, Obesity & Overweight, Muscle Loss
- What is being tested?
- Semaglutide, Dietary Counseling and Exercise
- Type of treatment
- 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
- 6 Apr 2026to 6 Aug 2026
- Phase
- Phase 4
- 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 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 40 and 55 years
- Body Mass Index (BMI) greater than 30
- Body fat percentage greater than 30% for males and 40% for females
- Android to gynoid fat ratio greater than 1.0
- Currently eligible for GLP-1 therapy
- No diagnosis of Type II diabetes
Who cannot join
- Presence of abnormal ECG findings, including arrhythmias or ischemic changes
- Hypertensive response to exercise, defined as systolic blood pressure exceeding 250 mmHg or diastolic pressure exceeding 115 mmHg
- Hypotensive response to exercise, defined as a drop in systolic pressure greater than 10 mmHg with increasing workload
- VO₂ max below 15 ml/kg/min
- Borg Rating of Perceived Exertion (RPE) greater than 19 during submaximal workloads
- Any contraindications to exercise as defined by ACSM guidelines
- Musculoskeletal limitations that prevent safe participation in exercise
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brad Lambert contact
About this study
Official title: Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment
Obesity remains a critical public health challenge and is associated with increased rates of morbidity, mortality, and chronic disease worldwide. In recent years, glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have emerged as highly effective pharmacological treatments for obesity, producing substantial weight loss and favorable metabolic improvements. These medications are now widely prescribed, with estimates suggesting that nearly 12% of Americans are currently using or have previously used GLP-1 therapies. Despite their demonstrated benefits, growing evidence indicates that GLP-1-associated weight loss may be accompanied by unintended reductions in skeletal muscle and bone mass. This potential side effect is of increasing concern, as muscle and bone are essential for metabolic health, physical function, injury prevention, and recovery from illness or surgical intervention.
Loss of skeletal muscle during weight reduction may negatively impact strength, mobility, insulin sensitivity, and long-term health outcomes. These risks may be further compounded in individuals experiencing reduced physical activity, mechanical unloading, or prolonged caloric deficits. In clinical and surgical populations, such as individuals undergoing orthopedic procedures, mechanical unloading and disuse already predispose patients to muscle and bone atrophy. When combined with pharmacologically induced weight loss, these factors may further hinder recovery, impair functional capacity, and compromise musculoskeletal integrity. As GLP-1 therapies are increasingly adopted across diverse populations, understanding how to preserve lean mass and bone health during treatment has become an important clinical and public health priority.
Read more
Exercise training, particularly resistance training, combined with appropriate nutritional support, has consistently been shown to preserve and enhance skeletal muscle and bone mass during weight loss. Structured exercise interventions can mitigate sarcopenia and osteopenia while improving muscular strength, cardiorespiratory fitness, metabolic health, and overall physical function. Similarly, individualized dietary counseling, particularly when focused on adequate protein intake and nutrient timing, plays a critical role in supporting muscle protein synthesis and skeletal health during caloric restriction. Together, these lifestyle strategies may not only counteract the potential adverse musculoskeletal effects associated with GLP-1 therapy but also enhance treatment efficacy by improving cardiovascular risk profiles, insulin sensitivity, systemic inflammation, and physical resilience.
Despite the growing use of GLP-1 medications, there remains a limited body of prospective research examining structured lifestyle interventions specifically designed to preserve muscle and bone mass during GLP-1-induced weight loss. Addressing this gap is essential to ensure that pharmacological obesity treatments support long-term health, functional independence, and quality of life. Integrating exercise and nutrition interventions into GLP-1 treatment protocols may represent a scalable and clinically meaningful strategy to optimize outcomes and reduce unintended consequences of rapid weight loss.
The purpose of this study is to evaluate whether a structured lifestyle intervention combining exercise and individualized nutritional counseling can mitigate skeletal muscle mass loss in obese adults undergoing treatment with GLP-1 receptor agonists. The primary objective of this study is to determine whether participation in a structured 12-week exercise program, in conjunction with individualized dietary counseling, preserves skeletal muscle mass and bone mineral density during GLP-1 therapy. Secondary objectives include assessing changes in muscular strength, cardiorespiratory fitness, and overall functional capacity. Findings from this study aim to inform best practices for integrating lifestyle interventions with pharmacological obesity treatments and to support safer, more effective, and functionally protective approaches to weight management in adults receiving GLP-1 therapy.
- Being tested
- Semaglutide, Dietary Counseling, Exercise
- Keywords
- GLP-1, Semaglutide, obesity, exercise intervention
- Medical subject headings
- Obesity, Overweight, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Wegovy®
FDA-approved GLP-1 receptor agonist administered once weekly per standard of care
Dietary CounselingBehavioural
Weekly individualized nutrition counseling focused on nutrition education, meal planning, and macronutrient intake to support lean mass preservation during GLP-1 therapy.
ExerciseBehavioural
A 12-week supervised and progressive exercise program consisting of resistance training and aerobic exercise performed three times per week at the Rice University Wellness Center.
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: GLP-1 Therapy Alone | Active comparator | Participants receive standard-of-care GLP-1 receptor agonist therapy (semaglutide) without additional exercise or dietary counseling. Receives: Drug: Semaglutide |
| Treatment Arm: GLP-1 Therapy + Exercise and Dietary Counseling | Experimental | Participants receive standard-of-care GLP-1 receptor agonist therapy (semaglutide) in combination with a 12-week structured exercise program and weekly individualized dietary counseling. Receives: Behavioral: Dietary Counseling; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skeletal Muscle Mass
Change in skeletal muscle mass measured by dual-energy X-ray absorptiometry (DEXA).
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start6 Apr 2026 (estimated)
- Primary completion29 Jun 2026 (estimated)
- Study completion6 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GLP - 1Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study uses a parallel-group design in which participants are randomized to either standard-of-care GLP-1 therapy alone or GLP-1 therapy combined with structured exercise and dietary counseling for 12 weeks.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07554417
- Sponsor's protocol ID
- IRB-FY2026-226
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be shared. Shared IPD will include demographic characteristics (e.g., age, sex), baseline and post-intervention outcome measures related to body composition, muscle mass, bone mineral density, muscular strength, cardiorespiratory fitness, dietary intake summaries, and selected laboratory values. All shared data will be stripped of direct identifiers and coded to prevent re-identification. No names, dates of birth, contact information, medical record numbers, or other direct personal identifiers will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment
- ClinicalTrials.gov ID
- NCT07554417
- Acronym / sponsor ID
- IRB-FY2026-226
- Keywords
- GLP-1, Semaglutide, obesity, exercise intervention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute
- Study start
- 6 Apr 2026 (estimated)
- Primary completion
- 29 Jun 2026 (estimated)
- Study completion
- 6 Aug 2026 (estimated)
- First posted
- 28 Apr 2026 (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.
Obesity remains a critical public health challenge and is associated with increased rates of morbidity, mortality, and chronic disease worldwide. In recent years, glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide, have emerged as highly effective pharmacological treatments for obesity, producing substantial weight loss and favorable metabolic improvements. These medications are now widely prescribed, with estimates suggesting that nearly 12% of Americans are currently using or have previously used GLP-1 therapies. Despite their demonstrated benefits, growing evidence indicates that GLP-1-associated weight loss may be accompanied by unintended reductions in skeletal muscle and bone mass. This potential side effect is of increasing concern, as muscle and bone are essential for metabolic health, physical function, injury prevention, and recovery from illness or surgical intervention.
Loss of skeletal muscle during weight reduction may negatively impact strength, mobility, insulin sensitivity, and long-term health outcomes. These risks may be further compounded in individuals experiencing reduced physical activity, mechanical unloading, or prolonged caloric deficits. In clinical and surgical populations, such as individuals undergoing orthopedic procedures, mechanical unloading and disuse already predispose patients to muscle and bone atrophy. When combined with pharmacologically induced weight loss, these factors may further hinder recovery, impair functional capacity, and compromise musculoskeletal integrity. As GLP-1 therapies are increasingly adopted across diverse populations, understanding how to preserve lean mass and bone health during treatment has become an important clinical and public health priority.
Exercise training, particularly resistance training, combined with appropriate nutritional support, has consistently been shown to preserve and enhance skeletal muscle and bone mass during weight loss. Structured exercise interventions can mitigate sarcopenia and osteopenia while improving muscular strength, cardiorespiratory fitness, metabolic health, and overall physical function. Similarly, individualized dietary counseling, particularly when focused on adequate protein intake and nutrient timing, plays a critical role in supporting muscle protein synthesis and skeletal health during caloric restriction. Together, these lifestyle strategies may not only counteract the potential adverse musculoskeletal effects associated with GLP-1 therapy but also enhance treatment efficacy by improving cardiovascular risk profiles, insulin sensitivity, systemic inflammation, and physical resilience.
Despite the growing use of GLP-1 medications, there remains a limited body of prospective research examining structured lifestyle interventions specifically designed to preserve muscle and bone mass during GLP-1-induced weight loss. Addressing this gap is essential to ensure that pharmacological obesity treatments support long-term health, functional independence, and quality of life. Integrating exercise and nutrition interventions into GLP-1 treatment protocols may represent a scalable and clinically meaningful strategy to optimize outcomes and reduce unintended consequences of rapid weight loss.
The purpose of this study is to evaluate whether a structured lifestyle intervention combining exercise and individualized nutritional counseling can mitigate skeletal muscle mass loss in obese adults undergoing treatment with GLP-1 receptor agonists. The primary objective of this study is to determine whether participation in a structured 12-week exercise program, in conjunction with individualized dietary counseling, preserves skeletal muscle mass and bone mineral density during GLP-1 therapy. Secondary objectives include assessing changes in muscular strength, cardiorespiratory fitness, and overall functional capacity. Findings from this study aim to inform best practices for integrating lifestyle interventions with pharmacological obesity treatments and to support safer, more effective, and functionally protective approaches to weight management in adults receiving GLP-1 therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study uses a parallel-group design in which participants are randomized to either standard-of-care GLP-1 therapy alone or GLP-1 therapy combined with structured exercise and dietary counseling for 12 weeks.
| Arm | Type | Receives |
|---|---|---|
| Control Arm: GLP-1 Therapy Alone | Active comparator | Drug: SemaglutideParticipants receive standard-of-care GLP-1 receptor agonist therapy (semaglutide) without additional exercise or dietary counseling. |
| Treatment Arm: GLP-1 Therapy + Exercise and Dietary Counseling | Experimental | Behavioral: Dietary Counseling, Behavioral: ExerciseParticipants receive standard-of-care GLP-1 receptor agonist therapy (semaglutide) in combination with a 12-week structured exercise program and weekly individualized dietary counseling. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 40 and 55 years
- Body Mass Index (BMI) greater than 30
- Body fat percentage greater than 30% for males and 40% for females
- Android to gynoid fat ratio greater than 1.0
- Currently eligible for GLP-1 therapy
Key exclusion criteria (7 listed)
- Presence of abnormal ECG findings, including arrhythmias or ischemic changes
- Hypertensive response to exercise, defined as systolic blood pressure exceeding 250 mmHg or diastolic pressure exceeding 115 mmHg
- Hypotensive response to exercise, defined as a drop in systolic pressure greater than 10 mmHg with increasing workload
- VO₂ max below 15 ml/kg/min
- Borg Rating of Perceived Exertion (RPE) greater than 19 during submaximal workloads
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 |
|---|---|---|
| SemaglutideAlso: Wegovy®FDA-approved GLP-1 receptor agonist administered once weekly per standard of care | Drug | Control Arm: GLP-1 Therapy Alone |
| Dietary CounselingWeekly individualized nutrition counseling focused on nutrition education, meal planning, and macronutrient intake to support lean mass preservation during GLP-1 therapy. | Behavioural | Treatment Arm: GLP-1 Therapy + Exercise and Dietary Counseling |
| ExerciseA 12-week supervised and progressive exercise program consisting of resistance training and aerobic exercise performed three times per week at the Rice University Wellness Center. | Behavioural | Treatment Arm: GLP-1 Therapy + Exercise and Dietary Counseling |
Primary outcome
Change in Skeletal Muscle Mass
Time frame: Baseline to 12 weeks
Change in skeletal muscle mass measured by dual-energy X-ray absorptiometry (DEXA).
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 28 Apr 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be shared. Shared IPD will include demographic characteristics (e.g., age, sex), baseline and post-intervention outcome measures related to body composition, muscle mass, bone mineral density, muscular strength, cardiorespiratory fitness, dietary intake summaries, and selected laboratory values. All shared data will be stripped of direct identifiers and coded to prevent re-identification. No names, dates of birth, contact information, medical record numbers, or other direct personal identifiers will be shared.
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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.
Brad Lambert contact
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, Dietary Counseling and Exercise in people with GLP - 1 and Obesity & Overweight, run by William Marsh Rice 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 6 inclusion and 7 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: opening soon, as of the sponsor's last update on 28 Apr 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.
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?
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 Anatolia Vick-Kregel (17135157991, av82@rice.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skeletal Muscle Mass (time frame: Baseline to 12 weeks). 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 28 Apr 2026.