NCT06854614Active, not recruitingPhase 4
Sequential Therapy Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)
Source: ClinicalTrials.gov · Last updated 30 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 150 (actual)
- First submitted
- 21 Feb 2025
- Start date
- 1 Mar 2025
- Primary completion date
- 28 Apr 2027
- Lead sponsor
- The Cleveland Clinic
- Diseases
- Obesity
- NCT number
- NCT06854614
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 150
- From 1 Mar 2025 to the primary completion date, 28 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current glucocorticoid therapy, except for maintenance glucocorticoid therapy of prednisone 5 mg or equivalent
- Currently or within the past 6 months receiving an anti-obesity medication, or any other medication used for the primary intent of weight loss
- previous history of pancreatitis, history of severe liver disease (Cirrhosis), or severe disease of digestive tract
- Prior participation in the Endocrinology and Metabolism Institutes Integrated Weight Management Program within the past 3 months
- Medications that affect physical performance (beta-blocker or others)
- Concurrent use of bupropion or naltrexone or previous intolerance to any of these medic
- Previous intolerance to use or allergy to any of the anti-obesity medications approved in this study
Other illness
- Patients with history of diabetes
- Glomerular Filtration Rate \<30 mL/min/1.73 m2 (calculated by the Chronic Kidney Disease Epidemiology Collaboration Equation, CKD-EPI)
- 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
- Personal or family history of medullary thyroid carcinoma
- Personal or family history of Multiple Endocrine Neoplasia syndrome type 2
- History of congestive heart failure
- History of bariatric or metabolic surgery/procedure
- Cardiovascular disease including uncontrolled hypertension, history of arrhythmias or coronary artery disease
- History of recurrent kidney stones
- History of glaucoma
- History of seizure disorders
- Uncontrolled lung disease (difficult to control Asthma or COPD)
- Uncontrolled thyroid disease
- History of malabsorptive disorders or cholestasis
- Conductive implanted devices (i.e. cardiac pacemaker, cardioverter-defibrillators)
Other
- Mental incapacity or language barrier
- Pregnancy or plans to become pregnant within the next 2 years
- Contraindication for physical activity or significant physical limitation
- Smoking
- Patients with personal commitments that limit optimal participation
Who the study is looking for
- Gender: men and women
- Ethnicity: all ethnic groups
- 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
Age in the registry: 25 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.