RecruitingPhase 2NCT07142252

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

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Enrollment

66 participants

Start Date

Mar 25, 2026

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes Mellitus

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.

Eligibility

Min Age: 8 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called rezpegaldesleukin (NKTR-358) — which is designed to calm the immune system by boosting regulatory T cells — as a treatment for newly diagnosed type 1 diabetes. In type 1 diabetes, the immune system mistakenly attacks insulin-producing cells in the pancreas, and this drug aims to slow or stop that process. People aged 8 to 45 diagnosed with type 1 diabetes within the past 100 days and who still have some remaining insulin production (measured by a C-peptide test) may be eligible. Participation involves subcutaneous injections every two weeks for 26 weeks, blood tests, and mixed meal tolerance tests, with follow-up visits for 12 months total. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRezpegaldesleukin

Rezpegaldesleukin will be dosed at 12 μg/kg for subcutaneous injection. Rezpegaldesleukin will be provided as a 1.5 mg/mL sterile solution in a vial for injection preparation. Study agent injections will be administered in the abdomen, back of the upper arm or the upper thigh of the participant.

DRUGPlacebo

Sterile saline for injection. Placebo will be administered in the same volume and as the active comparator to maintain treatment masking.