Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
NCT07091500

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

Led by Washington University School of Medicine · Updated on 2025-09-23

40

Participants Needed

1

Research Sites

207 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Obesity (Body Mass Index 30 kg/m2 or higher)
  • Decreased physical function with a Modified Physical Performance Test score between 17 and 31
  • Approval from primary physician to participate in the study
Not Eligible

You will not qualify if you...

  • Unstable weight with more than 4% change in the last 2 months before the study
  • Engaging in 150 minutes or more per week of structured exercise
  • Diagnosis of diabetes
  • Significant heart or lung diseases, uncontrolled high blood pressure, or other organ dysfunction (e.g., severe kidney problems)
  • Current use of GLP-1 or other weight loss medications
  • Serious stomach emptying problems or regular use of drugs affecting gastrointestinal movement
  • History of chronic or acute pancreatitis
  • Thyroid-stimulating hormone (TSH) greater than 1.5 times the upper limit of normal unless stable thyroid treatment for at least 3 months
  • Recent severe or unstable major depressive disorder or other serious psychiatric illness within 2 months
  • Acute or chronic hepatitis or other liver diseases except Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD)
  • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
  • Active or untreated cancer or remission less than 5 years for significant cancers (excluding certain skin and in situ cancers)
  • Tobacco use, excessive alcohol intake, active substance abuse, or recent marijuana use without willingness to abstain during the trial
  • Use of medications that affect study measures or pose risk and cannot be stopped temporarily
  • Previous or planned bariatric or endoscopic obesity surgery
  • Anemia with hemoglobin less than 10 g/dL
  • Conditions preventing completion of all testing procedures (e.g., severe mobility issues, limb amputations, metal implants interfering with imaging, coagulation disorders)
  • History of seizure disorder
  • Female who is pregnant, breastfeeding, or plans to become pregnant
  • Allergy or hypersensitivity to GLP-1 receptor agonist medications
  • Unable to provide informed consent
  • Unable or unwilling to follow study protocol or deemed unsuitable by research team

AI-Screening

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Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

C

Coordinator

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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