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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: Clinical Trial Phase 4 study, sponsored by The Cleveland Clinic.
NCT04531176 is a Phase 4 study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 74 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
All relevant time points used in the calculation in the Time Frame between baseline and 12 months. Measured in the mean Change in body weight between baseline and 12 months measured in percentage (%) of body weight loss
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 |
Why NCT04531176 stopped before completion
NCT04531176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 74 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 5 interventions - of which Weight Management Program (WMP) is the first listed.
NCT04531176 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04531176's enrollment target sits among peer trials
74 1027th of 2000 higher than 968 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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