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Engagement of experienced FDA regulatory counsel at this stage is not merely advisable, it is essential

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Benefits in trials are often mediated by metabolic improvements that correlate with weight loss and improved glycemic control

Measurable weight loss typically begins within two to four weeks

Endocrinol Nutr 59(3):197206 Devoto F, Zapparoli L, Bonandrini R, Berlingeri M, Ferrulli A, Luzi L et al (2018) Hungry brains: a meta-analytical review of brain activation imaging studies on food perception and appetite in obese individuals

Yet many continue to incur costs due to re-initiation or ongoing treatment for obesity-related conditions like type 2 diabetes, hypertension, or sleep apnea