IMPACT: Phase 2 randomized trial of IMCY-0098 proinsulin Imotope peptide in recent-onset T1D
What this study tests
Multicenter, randomized, double-blind, placebo-controlled Phase 2 trial (IMPACT) evaluating subcutaneous IMCY-0098 (proinsulin Imotope peptide) in 110 adolescents and adults with recent-onset Type 1 Diabetes. Formally terminated in 2024 after showing no C-peptide efficacy at the 1-year primary analysis.
Editorial review: .
Registry checked: 2026-10-26. Registry’s own update: 2024-06-24.
Most recent recorded citation date: 2024-06-24. 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?
- Patients aged 12–45 with recent-onset Stage 3 Type 1 Diabetes carrying HLA-DR3 and/or HLA-DR4 haplotypes and retaining fasting C-peptide >= 0.2 nmol/L. 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
- Terminated after completing enrollment of 110 participants. Registry termination reason: 'No efficacy at primary analysis after 1 year. Long term follow-up stopped.'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: European Union, United Kingdom, United States, 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
- Change from baseline in MMTT stimulated C-peptide AUC at Month 12
The full picture
Study design and outcome
Multicenter, randomized, double-blind, placebo-controlled Phase 2 trial (IMPACT / IMCY-T1D-003) evaluating subcutaneous IMCY-0098 (Imotope modified proinsulin peptide) in 110 adolescents and adults aged 12–45 with recent-onset Stage 3 Type 1 Diabetes carrying HLA-DR3 and/or HLA-DR4. Formally terminated in January 2024 (WhyStopped: "No efficacy at primary analysis after 1 year. Long term follow-up stopped").
Sources
- [1]NCT04524949: IMCY-0098 Proof of ACtion in Type 1 Diabetes (IMPACT) · Trial registry · 2024-06-24 — Recorded as TERMINATED with WhyStopped: 'No efficacy at primary analysis after 1 year. Long term follow-up stopped.'