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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 10 → 15 locationsv6
  2. Trial sites expanded: 3 → 10 locationsv5
  3. Start date changed from estimate of Mar 25, 2026 to May 14, 2026v4
  4. Trial status: Not Yet Recruiting to Recruiting Start date: Nov 13, 2025 to Mar 25, 2026 · Study sites: 1 to 3 · Primary completion date: May 13, 2028 to May 25, 2028 · 3 morev3 Show 6 more changesShow less
    • Start date: Nov 13, 2025 to Mar 25, 2026
    • Study sites: 1 to 3
    • Primary completion date: May 13, 2028 to May 25, 2028
    • Completion date: May 13, 2029 to May 25, 2028
    • Eligibility criteria revised
    • Secondary endpoints: 1 to 6

    See this version in full on ClinicalTrials.gov ↗

  5. Study sites: 0 to 1 Secondary endpoints expanded, about 7 wordsv2 Show 1 more changeShow less
    • Secondary endpoints expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov