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TLK286: phase I dose escalation trial in patients with advanced malignancies

Clinical research shows that many individuals lose 10-15% of their starting body weight, and some may lose even more with consistent use and lifestyle support

Long-term adherence studies indicate that metabolic benefits persist as long as treatment continues, with some evidence suggesting that early intervention may help preserve beta-cell function and delay or prevent progression to insulin-dependent diabetes

Regulatory uncertainty persists, as the FDA has yet to finalize its guidance on GLP-1 biosimilars, creating a timing risk for follow-on entrants