A Breakthrough Backed by Clinical Evidence The FDAs decision was supported by data from the OASIS 4 Phase 3 clinical trial , which followed 307 adults without diabetes over a 64-week period
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According to DSM-5-TR criteria, BED severity is classified as mild (1-3 episodes/week), moderate (4-7 episodes/week), or severe (8+ episodes/week), with each level requiring appropriate treatment intensity
Dose escalation followed a stepwise schedule, progressing from 2 mg up to a maximum of 12 mg once weekly over several months, depending on tolerability
The risk is real but substantially modifiable which is another argument for supervised rather than unsupervised GLP-1 use