drugset / Trial / NCT07142252

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

NCT07142252

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2026-05-14
Primary completion
2028-05-25
Completion
2028-05-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Rezpegaldesleukin Protein / enzyme biologic 12 ug/kg Subcutaneous