ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-01

Study Completion:2028-04-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06854614

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.

Ages Eligible for Study:25 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Gender: men and women 2. Ethnicity: all ethnic groups 3. Age: ≥ 25, \< 65 years	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)

Inclusion Criteria

Exclusion Criteria

1. Gender: men and women
2. Ethnicity: all ethnic groups
3. Age: ≥ 25, \< 65 years

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)

Contacts and Locations

Principal Investigator

Bartolome Burguera, M.D

PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01

Study Completion Date2028-04-28

Study Record Updates

Study Start Date2025-03-01

Study Completion Date2028-04-28

Terms related to this study

Additional Relevant MeSH Terms

Obesity