ASITI-201 (proinsulin peptide / calcitriol liposomes)
UniQuest / University of Queensland (Liperate Therapeutics)
What it is
An antigen-specific liposome that packages a proinsulin peptide with calcitriol (active vitamin D), being tested in a Queensland Phase 1 trial in adults with stage 3 T1D. The registry says Part A is complete and Part B is recruiting. No efficacy results are posted.
Editorial review: .
Most recent recorded citation date: 2026-07-02. 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 behind this assessment
Key evidence notes. Study results, product eligibility and access answer different questions.
- Who was studied?
- Study populations and analysis groups vary. Product age limits alone do not describe who was studied.See the linked studies and their populations →
- Benefit or performance
- Beta-cell preservation: The registered trial is a safety study. Mixed-meal C-peptide is a Part B secondary measure at three months, not a posted result. No human preservation result is posted.[1]
- Important harms and treatment burden
- Safety: Primary endpoint is short-term safety of single and multiple subcutaneous doses. The registry records Part A (single-dose escalation) as complete and Part B (three weekly doses) as recruiting. No safety results are posted.[1]
- Approval and country access
- Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
- Follow-up and remaining uncertainty
- Durability: Follow-up in the protocol is measured in weeks to three months. No results are posted, so there is no evidence that any immune effect lasts after the injections stop.[1]
Research status alone does not establish approval, clinical benefit or local availability.
Editorial score: calculation and evidence
A weighted editorial judgment on a 0–100 scale, not a probability of success or a measured treatment effect. Higher criterion scores mean more favorable assessments.
Default calculation: 8 × 30 + 5 × 20 + 34 × 20 + 18 × 10 + 20 × 20 = 1600; divide by total weight 100. Unrounded weighted result: 16.
The registered trial is a safety study. Mixed-meal C-peptide is a Part B secondary measure at three months, not a posted result. No human preservation result is posted.[1]
Follow-up in the protocol is measured in weeks to three months. No results are posted, so there is no evidence that any immune effect lasts after the injections stop.[1]
Primary endpoint is short-term safety of single and multiple subcutaneous doses. The registry records Part A (single-dose escalation) as complete and Part B (three weekly doses) as recruiting. No safety results are posted.[1]
Adults 18–55 with stage 3 T1D diagnosed within five years, residual C-peptide at least 0.2 nmol/L (about 0.6 ng/mL), at least one islet autoantibody, and HLA-DQ8 or HLA-DQ2 (DQB1-03:02 or DQB1-02:01). Not children, not stage 1–2, not HLA-unselected.[1]
Human Phase 1, placebo-controlled, recruiting in Queensland. Target n=36; accrual 27 as of the 2 July 2026 registry update. No results posted.[1]
The full picture
ASITI-201 is a second-generation antigen-specific immunotherapy: a tiny fat particle that carries a piece of proinsulin together with calcitriol, injected under the skin. The programme hypothesis is that it re-teaches immune cells to tolerate beta-cell protein rather than attack it. It is not a treatment you can get, and with no results posted it has not been shown to preserve insulin production in people.
The registered human study is a Queensland Phase 1 (ACTRN12624001043527) in adults with stage 3 T1D, residual C-peptide, and selected HLA-DQ types. Part A (single-dose escalation) is complete; Part B (three weekly doses) is recruiting. Safety is the primary question. A three-month mixed-meal C-peptide test in Part B is secondary. Until those numbers are posted, this record stays an early safety programme — scored as a first-in-human safety study.
Coming soon
ETA · Phase 1 recruiting in Queensland; no efficacy timeline
Sources
- [1]ASITI-201-T1D: safety, tolerability and immune modulation of proinsulin peptide/calcitriol liposomes in stage 3 T1D · Trial registry · 2026-07-02 — ACTRN12624001043527. Recruiting. Last updated 2 July 2026. Target n=36; accrual to date 27. Part A complete; Part B recruiting. First participant 13 November 2024. Anticipated last enrolment 31 October 2026.
- [2]World-first immunotherapy trial to treat Type 1 diabetes · Science journalism · 2025-04-11 — University of Queensland announcement that dosing had begun. A press count of early participants is not a result and is older than the registry's 27-person accrual.