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Although extremely costly and time-consuming, these outcome trials have, nevertheless, provided us with extremely valuable information about the natural history of the diseases, drug safety and the influence of the drugs on the disease progression
Key regulatory themes include: Accelerated approvals for high-demand therapies
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AMG 133 demonstrated significant dose-dependent weight loss in a phase 1 randomized, double-blind, placebo-controlled clinical trial involving participants with obesity, along with an acceptable safety and tolerability profile [124]
In terms of the renal effects, there was not direct in-depth information reported regarding kidney toxicity, however there was no evidence of organ toxicity found in the overall literature, which included preclinical models (e.g., rats and mice)
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