Loading
Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 30, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 4 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
This record has not been graded across any dimension yet. Treat the label above as provisional and read the source.
What is missing. This record has no bottom line, key findings, reported figures, evidence dimensions. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06854614). This is a study registration, not published results. Lead sponsor: The Cleveland Clinic. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 150 participants (ACTUAL). Conditions: Obesity. Interventions: OTHER: Comprehensive weight loss; OTHER: Enhanced lifestyle changes; DRUG: Tirzepatide; DRUG: Naltrexone-Bupropion; DRUG: Phentermine-Topiramate; DRUG: Semaglutide (Wegovy®). Primary outcome measures: Weight change , month 9 to month 21. Brief 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 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.