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This result surpasses the 6% weight loss seen in semaglutide over a similar time frame [127]

Intestinal glucagon-like peptide-1 effects on food intake: physiological relevance and emerging mechanisms

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Devices that are part of the Breakthrough Devices Program, have received FDA marketing authorization for the indication covered by the Breakthrough Devices designation, and meet the other criteria in the regulation can be approved through the quarterly process and announced through that process (81 FR 79655)