ASITI-201 Phase 1 in stage 3 T1D (Queensland)
Recruiting Australian Phase 1, randomised, double-blind, placebo-controlled study of subcutaneous proinsulin peptide/calcitriol liposomes (ASITI-201) in adults with stage 3 T1D. Part A (single-dose escalation) is complete; Part B (three weekly doses) is recruiting. Safety is the primary endpoint. No results are posted.
Primary endpoints
- Short-term safety of single and multiple ASITI-201 doses (adverse events, labs, withdrawals)
Results so far
No results posted. Recruiting. Target n=36; accrual 27 as of the 2 July 2026 ANZCTR update. First participant 13 November 2024. Anticipated last enrolment 31 October 2026; last data collection 31 January 2027. Registry brief states Part A is complete and Part B is recruiting. April 2025 university news that five people had been dosed is not a result and is older than the registry accrual.
The full picture
This is a first-in-human antigen-specific liposome study, not a preservation trial. Mixed-meal C-peptide at three months is a Part B secondary outcome. Do not read university “world-first” coverage, or the fact that Part A finished, as evidence that remaining beta cells are protected.