← Trials/Trial dossier/NCT07091500

RecruitingPhase NA

Glucagon-like Peptide 1 (GLP-1) Receptor Agonist Therapy and Exercise Training in People With Obesity

Effect of GLP-1 Receptor Agonist Therapy With and Without Exercise Training on Muscle Mass and Physical Function in People With Obesity

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

40

estimated

Study population

Obesity / overweight, Sarcopenia / muscle

Key I/E criterion

BMI ≥30

Primary endpoints

Physical functionBody composition

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07091500
Org study ID202505162

Timeline

Milestones

Study first posted2025-07-29actual
Study start2025-08-11actual
Last update posted2025-09-23actual
Primary completion2028-08-01estimated
Study completion2029-08-01estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightSarcopenia / muscle

Eligibility

Who can enroll

Minimum age50 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

i) obesity (Body Mass Index ≥ 30 kg/m2)
ii) decreased physical function (Modified Physical Performance Test score 17 to 31)
iii) approval of their primary physician to participate in this study.

Exclusion criteria

i) unstable weight (>4% change during the last 2 months before entering the study)
ii) ≥150 min per week of structured exercise (e.g., jogging, activities that cause heavy breathing and sweating)
iii) diabetes
iv) significant cardiopulmonary disease (heart failure, angina, uncontrolled hypertension, chronic obstructive pulmonary disease) or other organ dysfunction (e.g., renal insufficiency [eGFR <30 mL/min/1.73 m2])
v) therapy with a GLP-1 or other weight loss medications
vi) clinically significant gastric emptying abnormality or chronically take drugs that directly affect gastrointestinal motility
vii) history of chronic or acute pancreatitis
viii) thyroid-stimulating hormone (TSH) >1.5X the upper limit of normal (patients receiving treatment for hypothyroidism may be included provided their thyroid hormone replacement dose has been stable for at least 3 months)
ix) history of significantly active or unstable Major Depressive Disorder or other severe psychiatric disorder (e.g. schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 months that would interfere with study participation
x) acute or chronic hepatitis, or other liver disease other than Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)
xi) family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
xii) history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years
xiii) tobacco use, excessive alcohol intake (≥3 drinks/day for men and ≥2 drinks/day for women) or active substance abuse with illegal drugs by self-report, or regular marijuana use within 3 months of enrollment and unwilling to abstain from marijuana during the trial
xiv) Use of medications that are known to affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued for this study
xv) have had bariatric surgery or plan to have endoscopic or bariatric surgery therapy for obesity
xvi) anemia (Hgb <10 g/dL)
xvii) Conditions that render subject unable to complete all testing procedures (e.g., severe ambulatory impairments, limb amputations, or metal implants that interfere with imaging procedures; coagulation disorders)
xii) history of seizure disorder
xix) Female who is pregnant, breast-feeding or intends to become pregnant
xx) allergy or hypersensitivity to GLP-1 RA medications
xxi) unable to grant voluntary informed consent
xxii) unable or unwilling to follow the study protocol or who, for any reason, the research team considers the participant is not an appropriate candidate for the study

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
5
Other clinical outcomes
3
Glycemic / diabetes
1

Weight & body composition

5 endpoints
Primary/protocol endpoint/low confidence

Body composition

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

change from baseline, improvement

Secondary/protocol endpoint

Muscle mass

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Muscle volume

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Muscular Strength for the Seated Row exercise

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

descriptive

Secondary/protocol endpoint/low confidence

Muscular Strength for the Leg Press exercise

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Insulin sensitivity

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other clinical outcomes

3 endpoints
Primary/protocol endpoint

Physical function

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

descriptive, improvement

Secondary/protocol endpoint/low confidence

Muscular Strength for the Chest Press exercise

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Muscular Strength for the Leg Flexion exercise

Time frame:Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.