STEP-4 (withdrawal trial)
The Phase 3 trials that won approval, and the outcome studies that came afterward on cardiovascular, kidney and sleep-apnea endpoints.
What is STEP-4 (withdrawal trial)?
The withdrawal trial that settled whether a GLP-1 is a course or a commitment.
All 803 participants reached 2.4 mg in a 20-week run-in, then were randomized 2:1 to continue or switch to placebo for 48 weeks. Continuers lost a further 7.9%; switchers regained 6.9% (Rubino 2021 JAMA, PMID 33755728). ⛔ Read it before signing a 12-month prepay, and before believing anyone selling a finite “program”.
GLP Watchdog writes these definitions from FDA labels and peer-reviewed PubMed literature.
Where STEP-4 (withdrawal trial) comes up on this site
On GLP Watchdog, STEP-4 comes up in 1 tool.
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Other terms under Major trials
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