HDV-lispro Phase 2b liver-targeted insulin trial: review notes

Outcome: No new discrepancy identified in the reviewed summary, stated design, primary endpoint and eligibility against the available registry. This is a bounded protocol comparison, not confirmation of efficacy.

Registry: NCT06238778. Registered endpoint checked: hypoglycemia events (during the first 6 weeks of the maintenance period); hypoglycemia percentage of time (during the first 6 weeks of maintenance period). Eligibility check: Registry age 18 Years to 79 Years; substantive diagnosis/stage, device and other inclusion restrictions were compared with the public eligibility summary. The registry remains the source for full exclusions. Limits: No usable primary abstract was independently recovered in this pass for this record. Protocol/design wording was assessed; any existing detailed sponsor, conference or historical outcome claims require their cited source and were not independently certified through full-text review.

Assessment: Added June 7 Diasome primary sponsor report: composite primary endpoint failed; later maintenance analyses are secondary. Severe hypoglycemia 0 versus 5, P=.0598 not significant. Registry 227 versus sponsor 226 discrepancy retained explicitly below.

Registry: NCT06238778; COMPLETED; updated 2026-07-31; enrollment 227 (ACTUAL); results not posted.

Endpoint comparison: hypoglycemia events (during the first 6 weeks of the maintenance period); hypoglycemia percentage of time (during the first 6 weeks of maintenance period).

Sources for this record: NCT06238778: HDV-insulin lispro Phase 2b trial (registry); Diasome presents Phase 2b HDV-insulin lispro data (manufacturer).

Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.