Clinical Trial

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

Recruiting Phase 2
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Summary
This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.
Protocol Amendment History 1 change
notable Trial sites expanded: 3 -> 10 locations 2026-06-19
Trial Details
NCT Number NCT07142252
Lead Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Type 1 Diabetes Mellitus
Enrollment 66 participants
Start Date 2026-05-14
Primary Completion 2028-05-25 (estimated)
Study Completion 2028-05-25 (estimated)
Updated on ClinicalTrials.gov 2026-06-18