BEHAVIORAL
Exercise training
Participants will perform supervised exercise training sessions 3 days per week and unsupervised at-home sessions 2-3 days per week.
Status
Recruiting
Phase
Not applicable
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study summary
The use of glucagon-like peptide receptor agonists (GLP-1 RAs) may have clinically important effects on skeletal muscle mass (SMM), and physical function. The effects of exercise training in conjunction with GLP-1 RA therapy on these outcomes has not been studied. Additionally, most people treated with GLP-1-based weight loss medications stop taking these medications within 1 year of initiating treatment. This is an important clinical concern because weight regain can occur after weight loss pharmacotherapy is stopped and the impact of stopping GLP-1 RA therapy on physical and metabolic function has not been studied. In this study, the investigators will conduct a 2-year randomized clinical trial to evaluate body composition, muscle, physical and metabolic function, muscle strength and appetite control and reward signaling in the brain in response to 1-year of GLP-1 RA therapy, with or without exercise training, and subsequent treatment cessation on muscle and appetite-related outcomes assessed 1-year after stopping treatment.
Interventions
BEHAVIORAL
Participants will perform supervised exercise training sessions 3 days per week and unsupervised at-home sessions 2-3 days per week.
DRUG
semaglutide 2.4 mg subcutaneous per week or max tolerated dose and diet behavior counseling
BEHAVIORAL
After 1 year of treatment, participants will stop taking GLP-1 medications (and exercise, if applicable)
Timeline
First posted
Jul 29, 2025
Study start
Aug 11, 2025
Primary completion
Aug 1, 2028
Study completion
Aug 1, 2029
Results posted
Not reported
Registry updated
Jul 10, 2026
Outcomes
Physical function
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Score on the Modified Physical Performance Test
Body composition
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
DEXA scan
Muscle mass
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Whole-body muscle mass will assessed by using the D3-creatine dilution method
Muscle volume
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Magnetic resonance scans
Insulin sensitivity
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Whole-body insulin sensitivity during a hyperinsulinemic-euglycemic clamp
Muscular Strength for the Chest Press exercise
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Upper body muscle strength will be assessed as a ten repetition maximal strength for the chest press exercise on a Hoist multi-station weight machine
Muscular Strength for the Seated Row exercise
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Upper body muscle strength will be assessed as a ten repetition maximal strength for the seated row exercise
Muscular Strength for the Leg Press exercise
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Lower body muscle strength will be assessed as a ten repetition maximal strength for the leg press exercise
Muscular Strength for the Leg Flexion exercise
Time frame · Baseline, after 52 weeks of intervention, and 52 weeks after stopping the intervention
Lower body muscle strength will be assessed as a ten repetition maximal strength for the leg flexion exercise
Neural Connectivity
Time frame · Before (baseline), at the end of dose escalation (around weeks 18-20), at the end of maximal treatment (around 52 weeks), and after treatment cessation (anytime after 60 weeks) in a subset of participants randomized to the semaglutide only group.
GLP-1 receptor-agonist-induced neural connectivity as determined by functional magnetic resonance imaging (fMRI) scanning
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Washington University School of Medicine
St Louis, Missouri, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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