INSPIRE-T1D: JAK1 inhibitor ivarmacitinib for beta-cell preservation in new-onset T1D
What this study tests
A randomized, double-blind, placebo-controlled phase 2 trial in China evaluating whether oral ivarmacitinib (a selective JAK1 inhibitor) preserves residual beta-cell function over 52 weeks in newly diagnosed stage 3 T1D.
Editorial review: .
Registry checked: 2026-10-19. Registry’s own update: 2026-09-29.
Most recent recorded citation date: 2026-09-29. 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?
- Individuals aged 10–40 years within 100 days of confirmed stage 3 T1D diagnosis with peak MMTT-stimulated C-peptide at least 0.2 pmol/mL (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
- No results posted. Registry checked 19 October 2026 (ClinicalTrials.gov last update 29 September 2026): not yet recruiting; estimated n=132; estimated primary completion August 2029.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: Other regions. 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 Week 52
The full picture
What the study asks
INSPIRE-T1D is a multicenter, randomized, double-blind, placebo-controlled phase 2 study testing whether oral ivarmacitinib (8 mg once daily for 52 weeks), a selective Janus kinase 1 (JAK1) inhibitor, preserves endogenous insulin secretion in people with newly diagnosed stage 3 type 1 diabetes.1
Who it involves
Participants aged 10–40 years within 100 days of confirmed stage 3 type 1 diabetes diagnosis who have peak mixed-meal tolerance test (MMTT)-stimulated C-peptide of at least 0.2 pmol/mL (0.2 nmol/L). Standard infection, hematologic, hepatic, and renal exclusions apply.1
Design and timing
The registry plans 132 participants across clinical centers in China. The primary endpoint is change from baseline in MMTT-stimulated C-peptide area under the curve (AUC) at Week 52. Estimated primary completion is August 2029 and estimated study completion is December 2029.1
Evidence and limits
No results are posted, and the study is listed as not yet recruiting as of 19 October 2026. A registered protocol for a selective JAK1 inhibitor does not establish efficacy or safety in type 1 diabetes.1
Sources
- [1]Ivarmacitinib in Patients With New-Onset Type 1 Diabetes Mellitus (INSPIRE-T1D, NCT07845955) · Trial registry · 2026-09-29 — Protocol and current registry status checked 19 October 2026: NOT_YET_RECRUITING; estimated n=132; last update posted 29 September 2026; no results posted.
ClinicalTrials.gov. NCT07845955. Record checked 19 October 2026; first posted and last updated 2026-09-29.