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New England Journal of Medicine (2025) The REDEFINE 1 Phase 3 trial was a landmark 68-week, double-blind, randomized study comparing CagriSema (cagrilintide 2.4 mg plus semaglutide 2.4 mg) with semaglutide alone, cagrilintide alone, and placebo in 3,417 adults with obesity or overweight without diabetes

FDA staff scientists had unanimously opposed every peptide being added to the list, citing a lack of solid clinical trial data, inconsistent recipes from batch to batch and the risk the compounds could trigger harmful immune reactions

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DOSAGE: (Adults 18 years and older): Take one tablet daily, or as recommended by a healthcare practitioner

Although side effects seem to be in line with other weight loss drugs, long-term safety and real-world data will take time to build