Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06854614 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: STAY-LEAN
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Interventions modified
    • Eligibility criteria expanded, about 30 words
    • Study description shortened, about 6 words
    • Study title shortened, about 1 word
  2. Primary completion date: Dec 31, 2025 to Apr 28, 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 31, 2026 to Apr 28, 2028
    • Site details revised
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The Cleveland Clinic
212 trials monitored
See 33 trials at risk
Obesity
3,874 trials monitored
See 152 trials at risk
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.
Trial Details
NCT Number NCT06854614
Lead Sponsor The Cleveland Clinic
Conditions
(from sponsor)		 Obesity
Related terms Obesity
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov