RESET T1D: rezpegaldesleukin (NKTR-358), a Treg-selective IL-2, in new-onset T1D
What this study tests
A TrialNet phase 2 trial testing whether rezpegaldesleukin, an engineered IL-2 therapy described as intended to expand regulatory T cells, preserves insulin production after a recent T1D diagnosis. Per the registry, the planned enrollment is 66; clinical benefit has not yet been reported.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-09-08.
Most recent recorded citation date: 2026-09-08. 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?
- Ages 8-45 in the protocol, with enrollment stepping down by age after safety reviews; the registry does not establish which age bands are open at each site today. Diagnosed with type 1 diabetes within 100 days, at least one islet autoantibody, and stimulated C-peptide of at least 0.2 pmol/mL on a mixed-meal test done at least 21 days after diagnosis. The first ~18 participants must be 18-45; ages 12-17 open only after a favourable safety review, and ages 8-11 only after a second review. If a review is unfavourable, the younger age bands may never open. 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 yet. The trial started on 14 May 2026 and runs to an estimated completion of 25 May 2028.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: United States, Canada. 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
- Mean area under the stimulated C-peptide curve over a 2-hour mixed-meal tolerance test at 12 months
The full picture
What the trial tests
RESET T1D compares rezpegaldesleukin (NKTR-358) with placebo after a recent type 1 diabetes diagnosis. The drug is described as designed to expand regulatory T cells. Whether that produces lasting beta-cell preservation is the question being tested, not an established benefit.1
Design and eligibility
The protocol plans 66 participants, randomized 2:1 to active treatment or placebo with triple masking. Treatment is 12 micrograms/kg by injection every 14 days for 26 weeks, with follow-up to 12 months. Key eligibility requirements include diagnosis within 100 days, at least one islet autoantibody, and stimulated C-peptide of at least 0.2 pmol/mL on a mixed-meal test at least 21 days after diagnosis. The full registry lists additional clinical and laboratory criteria.1
The registry-listed primary endpoint is stimulated C-peptide area under the curve during a two-hour mixed-meal test at month 12. Other immunotherapy trials also use C-peptide, but differing populations, methods and time points can make a simple comparison of treatment effectiveness between studies misleading.1
Age cohorts and locations
The protocol covers ages 8–45 in stages. The first 18 participants must be adults. Ages 12–17 can be screened after a favorable safety review; ages 8–11 require a further favorable review after 17 additional participants, including at least nine aged 12–17, reach their six-month visit. If those reviews do not support expansion, enrollment continues at the approved age threshold.1
The registry does not establish which age cohorts are open today. Families should confirm current age eligibility with the study team. As of the registry update posted 8 September 2026, 15 sites are listed: 14 US sites recruiting and the University of British Columbia in Canada not yet recruiting. A registry recruitment label does not guarantee an available place.1
Results and timing
The registry lists a start date of 14 May 2026 and an estimated completion of 25 May 2028. No results are posted. The completion date is a study estimate, not a promised publication date. NIDDK is the registered sponsor; the registry record describes consultation with Nektar's safety group for the age-cohort reviews.1
Sources
- [1]Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Trial registry · 2026-09-08 — Current registry checked 16 September 2026: 66 estimated participants, protocol ages 8–45 with staged safety reviews, 15 listed sites (14 US recruiting; one Canadian not yet recruiting). Site status does not confirm which age cohorts are currently open.
ClinicalTrials.gov. RESET T1D, NCT07142252. Last update posted 8 September 2026; checked 16 September 2026.