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

Description

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.

Conditions

Obesity

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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)

Ages Eligible for Study

25 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

The Cleveland Clinic,

Bartolome Burguera, M.D, PRINCIPAL_INVESTIGATOR, The Cleveland Clinic

Study Record Dates

2026-12-31