Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)

Launched by THE CLEVELAND CLINIC · Feb 25, 2025

Keywords

ClinConnect Summary

The STAY-LEAN Trial is a research study looking at different ways to help people with obesity lose weight and keep it off while preserving muscle. The study will last for 21 months and will involve a comprehensive weight loss program at the Cleveland Clinic. Participants will first be given one of two medications—either tirzepatide or semaglutide—for 9 months to help with weight loss. After this initial phase, they will continue with the weight loss program and be randomly assigned to a different oral medication for another 12 months. The goal is to see how much weight participants lose after 21 months compared to after 9 months.

To be eligible for the trial, participants need to be between 25 and 65 years old, have a body mass index (BMI) of 30 or higher but less than 45, and be either a Cleveland Clinic employee or related to one. However, people with certain medical conditions, such as diabetes, severe kidney disease, or a history of specific surgeries, cannot participate. Throughout the trial, participants will receive support for their lifestyle changes, and their progress will be monitored closely. This study aims to find the most effective treatment for weight loss while ensuring the safety and health of everyone involved.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Gender: men and women
• • 2. Ethnicity: all ethnic groups
• • 3. Age: ≥ 25, \< 65 years
• • 5. Obesity, BMI ≥ 30 and BMI \< 45 6. An Employee, or the significant other of an employee, that is covered by the Cleveland Clinic Employee Health Plan
• Exclusion Criteria:
• • 1. Patients with history of diabetes
• • 2. Glomerular Filtration Rate \<30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)
• • 3. Current glucocorticoid therapy, except for maintenance glucocorticoid therapy of prednisone 5 mg or equivalent
• • 4. Currently or within the past 6 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss
• • 5. Any condition, unwillingness, or inability, not covered by any of the other exclusion criteria, which, in the study clinician's opinion, might jeopardize the subject's safety or compliance with the protocol
• • 6. Mental incapacity or language barrier
• • 7. Pregnancy or plans to become pregnant within the next 2 years
• • 8. Personal or family history of medullary thyroid carcinoma
• • 9. Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
• • 10. previous history of pancreatitis, history of severe liver disease (Cirrhosis), or severe disease of digestive tract
• • 11. History of congestive heart failure
• • 12. History of bariatric or metabolic surgery/procedure
• • 13. Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program within the past 3 months
• • 14. Contraindication for physical activity or significant physical limitation
• • 15. Smoking
• • 16. Cardiovascular disease including uncontrolled hypertension, history of arrhythmias or coronary artery disease
• • 17. History of recurrent kidney stones
• • 18. History of glaucoma
• • 19. History of seizure disorders
• • 20. Uncontrolled lung disease (difficult to control Asthma or COPD)
• • 21. Medications that affect physical performance (beta-blocker or others)
• • 22. Uncontrolled thyroid disease
• • 23. Patients with personal commitments that limit optimal participation
• • 24. Concurrent use of bupropion or naltrexone or previous intolerance to any of these medic
• • 25. Previous intolerance to use or allergy to any of the anti-obesity medications approved in this study
• • 26. History of malabsorptive disorders or cholestasis
• • 27. Conductive implanted devices (i.e. cardiac pacemaker, cardioverter-defibrillators)