drugset / Trial / NCT04531176

EMI-EHP Weight Management and Type 2 Diabetes Pragmatic Trial

NCT04531176

Phase 4 Terminated 74 enrolled The Cleveland Clinic
RandomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2020-09-01
Primary completion
2022-08-15
Completion
2023-08-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Liraglutide Peptide 3 mg
Subject Orlistat Small molecule
Subject naltrexone/bupropion Unknown
Subject phentermine/topiramate Unknown Oral