HDV-lispro Phase 2b liver-targeted insulin trial
What this study tests
Completed double-blind Phase 2b comparison of hepatocyte-directed-vesicle lispro with ordinary lispro in adults with T1D using insulin degludec, with 227 enrolled in the registry, focused on nocturnal level-2 hypoglycemia.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-07-31.
Most recent recorded citation date: 2024-02-02. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18-79 with T1D; see registry for full criteria. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- ClinicalTrials.gov has no posted results. Diasome’s June 2026 sponsor report says the composite primary endpoint was not met because the prespecified hypoglycemia superiority criterion failed during weeks 7–12. Favorable later maintenance-period findings are secondary. Severe hypoglycemia occurred in 0 versus 5 participants (P=0.0598), which does not establish a statistically significant reduction. The registry records 227 enrolled, while the sponsor report describes 226 randomized; these denominators are not interchangeable.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United States. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
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
The full picture
This record has no longer discussion. Use the study criteria, reported results and original sources on this page to assess what is known and what remains unresolved.
Sources
- [1]NCT06238778: HDV-insulin lispro Phase 2b trial · Trial registry · 2024-02-02 — COMPLETED; actual n=227; United States; no posted results as of 2026-08-08; registry update posted 2026-07-31.
- [2]Diasome presents Phase 2b HDV-insulin lispro data · Manufacturer — Sponsor report: primary composite endpoint failed; secondary maintenance analyses must remain distinct.