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The FDA strongly recommended that the firm engage a third-party consultant with relevant sterile drug manufacturing expertise to conduct a comprehensive assessment of operations

J Clin Endocrinol Metab (2020) 105(3):80320

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You might be a good fit for a clinical trial if: You meet typical enrollment criteria (like having obesity or overweight with a related health condition), and Youre open to the unknowns of an investigational treatment including potential side effects and the chance of receiving a placebo

About 50% of patients on ADMs used metformin only, with over 33% using insulin

Similar effects on HbA1c (Table 10) were observed in both treatment groups [see ADVERSE REACTIONS ]