AzTrials
AzTrials

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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

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
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.

Anatolia Vick-Kregel contact

17135157991

av82@rice.edu

Brad Lambert contact

bslambert@houstonmethodist.org

United States1 site
  • Rice University

    Houston, Texas, 77005

Other trials in United States

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 groups in NCT07554417
Study groupRoleWhat they receive
Control Arm: GLP-1 Therapy AloneActive comparatorParticipants 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 CounselingExperimentalParticipants 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.

  1. 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.

  1. First posted28 Apr 2026
  2. Study start6 Apr 2026 (estimated)
  3. Primary completion29 Jun 2026 (estimated)
  4. Study completion6 Aug 2026 (estimated)

Resources

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)
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.

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in