RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, and muscle strength in response to GLP-1 RA therapy, with or without exercise training, and subsequent treatment cessation on muscle-related outcomes.

Official Title

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

Quick Facts

Study Start:2025-08-11

Study Completion:2029-08-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07091500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Coordinator

CONTACT

314-273-1879

NutritionResearch@wustl.edu

Principal Investigator

Joseph W Beals, PhD

STUDY_DIRECTOR

Washington University School of Medicine

Samuel Klein, MD

PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Study Locations (Sites)

Washington University School of Medicine

St Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Washington University School of Medicine

Joseph W Beals, PhD, STUDY_DIRECTOR, Washington University School of Medicine
Samuel Klein, MD, PRINCIPAL_INVESTIGATOR, Washington University School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-11

Study Completion Date2029-08-01

Study Record Updates

Study Start Date2025-08-11

Study Completion Date2029-08-01

Terms related to this study

Additional Relevant MeSH Terms

Obesity
Skeletal Muscle