Clinical trial

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

Active, not recruiting · Phase 4 · 1 countries · Registry ID NCT06854614

Active, not recruitingPhase 4Interventional

What this study is about

This is a prospective, pragmatic, 21 month, single-center, randomized, 2-phased, open-label, parallel-group trial comparing the use of enhanced lifestyle changes (ELC) in two different sequential anti obesity medication (AOM) therapies. The ELC consists of a medically-supervised and comprehensive weight loss program (Cleveland Clinic's Department of Endocrinology, Diabetes and Metabolism's Integrated Weight Management Program). In the first phase (9 months) of the study, all participants will receive tirzepatide 15 mg (option #1) or semaglutide 2.4 mg if tirzepatide is not tolerated. In the second phase, after completing 9 months of tirzpeatide or semaglutide, participants will continue ELC and will be randomly assigned to a different oral AOM therapy for another 12 months: group 1 (phentermine-topiramate or naltrexone-bupropion) or group 2 (orlistat). The primary endpoint will be the percentage weight loss at 21 months compared to weight loss at 9 months. The goal will be to show superiority of the arm receiving ELC plus AOM therapy (phentermine-topiramate or naltrexone-bupropion) when compared to the other AOM therapy group (orlistat). Secondary and exploratory endpoints will include percentage of fat mass loss, lean muscle mass, functional capacity, muscle strength and compliance to enhanced lifestyle changes. Informed consent will be obtained. IRB approval of the study will be obtained.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age25 Years to 65 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity

Full registry 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)

Treatments and study arms

Comprehensive weight loss

Other

Shared Medical Appointments

Enhanced lifestyle changes

Other

Subjects will also be referred to an exercise physiologist for a personalized physical activity program. Physical Activity and Exercise will be discussed during SMAs as well and individually as needed for exercise progression The participants exercise prescription will be individualized based on an initial assessment. Exercise duration and progression will be recommended at the discretion of staff and exercise physiologist. The exercise program will be structured but flexible, which means patients can substitute group exercises with individual exercise if necessary, following the FITT-VP format (frequency, intensity, time, type, volume and progression). Patients can reduce exercise frequency if the duration is prolonged, or intensity is increased. Investigators will encourage patients to use Cleveland Clinic gyms across the enterprise.

Phentermine-Topiramate

Drug

Medication for chronic weight management (Rx)

Naltrexone-Bupropion Combination

Drug

Medication for chronic weight management (Rx)

Orlistat

Drug

Medication for chronic weight management (Rx)

Primary outcomes

Weight changemonth 9 to month 21

Weight change from month 9 month to month 21 in body weight (%) between both arms

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Cleveland Clinic🇺🇸 Cleveland, Ohio, United States