Gan & Lee Pharmaceuticals presents experimental insulin

Gan & Lee Pharmaceuticals presented results from two Phase I trials of their experimental once-weekly insulin analog, GZR4, at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD 2024). The trials assessed GZR4’s safety, tolerability, and efficacy in both healthy subjects and patients with Type 2 diabetes (T2DM).

Gan & Lee Pharmaceuticals

Phase Ia Study:

• Design: Placebo-controlled and active-comparator-controlled with dose-escalation.
• Participants: Healthy adult males.
• Results:
  • GZR4 showed good safety and tolerability with no serious adverse events.
  • The glucose-lowering effect of GZR4 persisted for approximately a week.
  • At the 6 nmol/kg dose, GZR4’s effectiveness was comparable to that of insulin degludec (IDeg), but GZR4 was estimated to be about 2.5 times more potent based on molar concentration.

Phase Ib Study:

• Design: Randomized, open-label, active-controlled, multi-center, dose-escalation.
• Participants: 36 T2DM patients previously on basal insulin.
• Results:
  • GZR4 reduced fasting blood glucose (FBG) and HbA1c levels more effectively than IDeg at various doses.
  • GZR4 was well-tolerated with no severe hypoglycemia reported.

Overall, GZR4 demonstrated promising safety and efficacy, and detailed results will be published in a peer-reviewed journal.

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