Weight loss program using anti-obesity medications and lifestyle changes
Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)
This study is testing a weight loss program that combines two different anti-obesity medications with lifestyle changes to see how much weight people can lose over 21 months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 25 Years to 65 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06854614 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of sequential anti-obesity medications combined with enhanced lifestyle changes over a 21-month period. Participants will first receive tirzepatide or semaglutide for 9 months, followed by a different oral anti-obesity medication for an additional 12 months. The study aims to assess the percentage of weight loss achieved at the end of the trial compared to the initial weight loss after the first phase. The trial is conducted at the Cleveland Clinic, utilizing a medically-supervised weight management program.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 65 with a BMI between 30 and 45 who are covered by the Cleveland Clinic Employee Health Plan.
Not a fit: Patients with a history of diabetes or those currently on anti-obesity medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to significant and sustained weight loss for patients struggling with obesity.
How similar studies have performed: Other studies have shown promising results with similar combinations of anti-obesity medications and lifestyle interventions.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Bartolome Burguera, M.D — The Cleveland Clinic
- Study coordinator: Andrea Debs, MS
- Email: debsa@ccf.org
- Phone: 216-445-8354
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.