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Chronic oral administration of high doses of levocarnitine in patients with severely impaired renal function or end-stage renal disease (ESRD) and dialysis patients may lead to accumulation of the potentially toxic metabolites trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), as these metabolites are normally excreted in the urine

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Pre-clinical models consistently showed durable glycemic and weight-loss effects, paving the way for expedited entry into human studies

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