NCT07142252

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 8 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This protocol will enroll 66 participants within 100 days of T1D diagnosis who will be treated with either rezpegaldesleukin or placebo with subcutaneous injections over 26 weeks, administered once every 14 days. The rezpegaldesleukin/placebo treatment will be administered at the study site. Mixed meal tolerance testing will be done at the screening, baseline visit (V0) and at 3, 6 and 12 months during the study. Once the 26-week treatment period has been completed, participants will continue follow-up visits until 12 months from the baseline visit.

Conditions

• Type 1 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2026-03-25
• Primary completion: 2028-05-25
• Completion: 2028-05-25
• First posted: 2025-08-26
• Last updated: 2026-04-02

Locations

3 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study