MedTrace Logo

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

NCT07142252 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

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

    lead NIH

Principal Investigators

  • Kevan Herold, MD · Type 1 Diabetes TrialNet Chairman

  • Daniel Moore, MD · Type 1 Diabetes TrialNet

  • Megan Levings, PhD · Type 1 Diabetes TrialNet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-25
Primary Completion
2028-05-25
Completion
2028-05-25
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07142252 on ClinicalTrials.gov