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NCT06854614 · ClinicalTrials.gov registry record · Phase 4
Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)
A Phase 4 study of Obesity, sponsored by The Cleveland Clinic.
- Active
- Registry status
- Phase 4
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT06854614: Active Phase 4 study of Obesity, sponsored by The Cleveland Clinic.
NCT06854614 is a Phase 4 study of Obesity that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 150 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06854614, a Phase 4 study of Obesity, is active but no longer recruiting, sponsored by The Cleveland Clinic.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 4
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
Weight change from month 9 month to month 21 in body weight (%) between both arms
Conditions Studied
Interventions
- DRUG Orlistat
- DRUG Naltrexone-Bupropion Combination
- DRUG Phentermine-Topiramate
- OTHER Comprehensive weight loss
- OTHER Enhanced lifestyle changes
Study Locations (1)
Ohio
- Cleveland Clinic - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2028-04-28 |
| Phase | Phase 4 |
What the registry record for NCT06854614 still lists
NCT06854614 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 5 interventions - of which Orlistat is the first listed.
NCT06854614 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT06854614 about?
NCT06854614 is a clinical study titled "Sequential or CombinaTion Anti-obesitY Medication With Muscle Preservation for Weight Loss and MaintEnance: A PragmAtic Randomized CoNtrolled Trial (STAY-LEAN Trial)". 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 we...
What is the current status of trial NCT06854614?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 150 participants. The study started on 2025-03-01. Estimated completion is 2028-04-28.
What conditions does trial NCT06854614 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT06854614?
The interventions under investigation include: Orlistat (DRUG), Naltrexone-Bupropion Combination (DRUG), Phentermine-Topiramate (DRUG), Comprehensive weight loss (OTHER), Enhanced lifestyle changes (OTHER).
Who is sponsoring clinical trial NCT06854614?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06854614 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06854614's enrollment target sits among peer trials
150 370th of 1053 higher than 668 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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