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Description

In both cases, different forms of regulatory interaction including Scientific Advice may occur in advance or in parallel to the FIH trial, to agree on the development plan, study design or specific aspects of the investigational compound

Patel D, Sethi N, Patel P, Shah S, Patel K

Before opening, leave the vial at room temperature for 15-30 minutes

REDEFINE Trial Headlines Trial REDEFINE 1 Phase 3 Duration 68 weeks Population (N) 3,417 adults with obesity or overweight + 1 comorbidity, without T2D Key Result 20.4% mean weight change vs 3.0% placebo (treatment-policy)