Trial · Interventional
Active, not recruitingPhase 4Registry dataSequential 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
- Ph 4
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.
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)
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
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