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type1.science
Phase 2CompletedNCT06238778

HDV-lispro Phase 2b liver-targeted insulin trial

Completed double-blind Phase 2b comparison of hepatocyte-directed-vesicle lispro with ordinary lispro in 227 adults with T1D using insulin degludec, focused on nocturnal level-2 hypoglycemia.

Primary endpoints

  • CGM-measured nocturnal level-2 hypoglycemia event rate during the first six weeks of maintenance
  • CGM-measured percentage of nocturnal time during the same period

Results so far

The study completed on 16 December 2025 with 227 participants. No results have been posted, so completion does not establish benefit.