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The weight loss was accompanied by improvements in glycemic control, with significant reductions in HbA1c levels, suggesting potential benefits for patients with both obesity and diabetes
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As of September 2023 it is on the FDA's Category 2 list of bulk drug substances that may not be compounded due to significant safety risks, and the agency has scheduled a Pharmacy Compounding Advisory Committee (PCAC) review for July 2026 covering proposed uses in opioid withdrawal, chronic insomnia, and narcolepsy
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Although some peptides are FDA-approved for specific medical conditions, their use in these wellness areas has not gone through the full regulatory approval process
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This phase 3 trial directly compares CagriSema 2.4 mg/2.4 mg against tirzepatide 15 mg in approximately 800 adults with obesity
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