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NCT04531176 · ClinicalTrials.gov registry record · Phase 4
EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial
A Phase 4 study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- Phase 4
- Development phase
- 74
- Enrollment target
NCT04531176 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 74 participants.
The verdict
NCT04531176, a Phase 4 study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 74 participants
- Enrollment target
Study Summary
This is a pragmatic, 24 month, single-center, randomized, open-label, parallel-group trial comparing an obesity-centric approach with a medically-supervised and comprehensive weight loss program (Cleveland Clinic's Endocrinology and Metabolism Institute's Integrated Weight Management Program) augmented by AOMs, vs. an obesity-centric approach with a medically-supervised and comprehensive weight loss program without AOMs, vs. the current usual care approach to general health management. Informed consent will be obtained. IRB approval of the study will be obtained. 300 subjects (employees or spouses covered by our EHP) will be randomized 1:1:1 to receive either an obesity-centric approach with AOM therapy (N=100), an obesity-centric approach without AOM therapy (N=100), or the current usual care approach to general health management (N=100).
Interventions
- OTHER Weight Management Program (WMP)
- OTHER Traditional care
- DRUG Phentermine / Topiramate Extended Release Oral Capsule
- DRUG naltrexone/bupropion extended-release
- DRUG liraglutide 3.0 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2020-09-01 |
| Est. Completion | 2023-08-04 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04531176
The ClinicalTrials.gov registry entry for NCT04531176 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Weight Management Program (WMP) is the first listed.
NCT04531176 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04531176 about?
NCT04531176 is a clinical study titled "EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial". This is a pragmatic, 24 month, single-center, randomized, open-label, parallel-group trial comparing an obesity-centric approach with a medically-supervised and comprehensive weight loss program (Cleveland Clinic's Endocrinology and Metabolism Institute's Integrated Weight Management Program) augmen...
What is the current status of trial NCT04531176?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 74 participants. The study started on 2020-09-01. Estimated completion is 2023-08-04.
What interventions are being tested in trial NCT04531176?
The interventions under investigation include: Weight Management Program (WMP) (OTHER), Traditional care (OTHER), Phentermine / Topiramate Extended Release Oral Capsule (DRUG), naltrexone/bupropion extended-release (DRUG), liraglutide 3.0 mg (DRUG).
Who is sponsoring clinical trial NCT04531176?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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