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Trial · Interventional

Active, not recruitingPhase 4Registry data

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

Short name STAY-LEAN

Overview

Status
Active, not recruiting
Phase
Phase 4
Enrollment
150 participants (actual)
Sponsor
The Cleveland Clinic · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
1 Mar 2025
Primary completion
28 Apr 2027 (estimated)
Completion
28 Apr 2028 (estimated)
First posted
3 Mar 2025
Last update posted
30 Sept 2026
Conditions
Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20252026202720282029
  1. Ph 4

    STAY-LEAN

    NCT06854614

    1 Mar 2025 to est. 28 Apr 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 therapy: sequential vs continuation of AOM. 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 Tirzepatide or Semaglutide, participants will continue ELC and will be randomly assigned to an AOM therapy for another 12 months: group 1 (phentermine-topiramate or naltrexone-bupropion) or continuation of the same therapy of the first 9 months - group 2 (Tirzepatide or Semaglutide) 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 continuation of Tirzepatide or Semaglutide when compared to the other AOM therapy group (phentermine-topiramate or naltrexone-bupropion). Secondary and exploratory endpoints will include percentage of fat mass loss, lean muscle mass, functional capacity, muscle strength and compliance to enhanced lifestyle changes. IRB approval of the study will be obtained. Informed consent will be obtained.

Interventions

  • Comprehensive weight lossOther
  • Enhanced lifestyle changesOther
  • TirzepatideDrug
  • Naltrexone-BupropionDrug
  • Phentermine-TopiramateDrug
  • Semaglutide (Wegovy®)Drug

Arms2

  • Experimental

    Group 1 AOM

    Comprehensive weight loss Program + Enhanced lifestyle changes + Group 1 AOM sequential therapy

  • Experimental

    Group 2

    Comprehensive weight loss + Enhanced lifestyle changes + Group 2 Continuation of Therapy

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Weight change

    Time frame · month 9 to month 21

    Registry description

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

Secondary outcomes(1)
  1. Change in body weight %

    Time frame · baseline to month 21

    Registry description

    Change from baseline to month 9, 15 and 21 in body weight (%)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 25 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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