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Phase 1RecruitingACTRN12624001043527

ASITI-201 Phase 1 in stage 3 T1D (Queensland)

What this study tests

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.

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

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Evidence at a glance

Who can enter the study?
Adults 18–55 with ADA-defined T1D diagnosed within five years, at least one islet autoantibody, residual C-peptide meeting the protocol criterion, and HLA-DQB1*03:02 or HLA-DQB1*02:01. LADA, current or prior treatment with a significant ongoing effect on T1D or immune status (including teplizumab, TNF inhibitors or JAK inhibitors), and current non-insulin glucose drugs are excluded. The listed site is Princess Alexandra Hospital, Queensland. Consult the trial team for the full C-peptide and other eligibility requirements. 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
No results documents are posted in the checked registry. Target n=36; accrual 27 in the 2 July 2026 ANZCTR update. First participant 13 November 2024. Anticipated last enrolment 31 October 2026; last data collection 31 January 2027. The registry states Part A is complete and Part B is recruiting. These are recruitment and protocol milestones, not evidence of efficacy.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: Australia. 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.

Primary endpoints

  • Short-term safety of single and multiple ASITI-201 doses (adverse events, labs, withdrawals)

The full picture

This antigen-specific liposome study primarily tests safety. Beta-cell preservation is an intended goal, and mixed-meal C-peptide at three months is a Part B secondary outcome. Completion of Part A does not establish that the treatment protects remaining beta cells.1

Sources

  1. [1]
    ACTRN12624001043527: ASITI-201 proinsulin peptide/calcitriol liposomes in stage 3 Type 1 Diabetes · Trial registry · 2026-07-02

    ANZCTR. ACTRN12624001043527, updated 2 July 2026: public title, outcomes and brief summary.