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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 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.

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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.

Conditions Studied

Obesity

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

FieldValue
Enrollment Target 150 participants
Start Date 2025-03-01
Est. Completion 2028-04-28
Phase Phase 4

Sponsor

The Cleveland Clinic

688 total trials

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What the Registry Record Tells You About NCT06854614

The ClinicalTrials.gov registry entry for NCT06854614 describes a study currently listed as active not recruiting, categorized as Phase 4. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (82% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.