Rezpegaldesleukin for New Onset Type 1 Diabetes
This study is testing a drug called Rezpegaldesleukin (NKTR-358) in people recently diagnosed with Type 1 Diabetes Mellitus (T1D). Researchers want to see if Rezpegaldesleukin can help preserve the body's natural insulin production. You might be able to join if you are between 8 and 45 years old and were diagnosed with T1D within the last 100 days. Half of the participants will receive Rezpegaldesleukin, and the other half will receive a placebo (an inactive substance like sterile saline). The main goal is to measure how much insulin your body makes after a meal over 12 months. The study is currently unclear on its recruitment status and plans to enroll 66 participants.
- Study design
- This is a Phase 2 study with 66 participants, where some receive Rezpegaldesleukin and others receive a placebo. Neither you, your care provider, nor the study staff will know which treatment you are receiving (double-masked).
- What's involved
- You would receive injections every 14 days for 26 weeks. You will also have mixed meal tolerance tests at the beginning, and at 3, 6, and 12 months, with follow-up visits until 12 months from the start.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 12 months after the start of the study, which includes a 6-month follow-up period after the 26-week treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07142252
Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
Recruiting
PHASE2Ages 8–45InterventionalTreatmentNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Government-funded
~66 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:RezpegaldesleukinPlacebo
At a glance
Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The area under the stimulated C-peptide curve (AUC) Y_MAUC.
Measured over 12 Months
Conditions
Where it's being run
10 sites across 9 statesFlorida2
Colorado1
Massachusetts1
New York1
Pennsylvania1
Tennessee1
Utah1
Washington1
Study leadership
- Kevan Herold, MD · STUDY_DIRECTOR · Type 1 Diabetes TrialNet Chairman
- Daniel Moore, MD · STUDY_CHAIR · Type 1 Diabetes TrialNet
- Megan Levings, PhD · STUDY_CHAIR · Type 1 Diabetes TrialNet
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Provide informed consent or assent as appropriate and if \< 18 years of age have a parent or legal guardian provide informed consent.
Age ≥ 8 and ≤ 45 years at the time of signing informed consent and (as applicable) assent A.
Diagnosis of T1D within 100 days of randomization.
Positive for at least one islet cell autoantibody; GAD65A, mIAA (if obtained within 10 days of the onset of insulin therapy), IA-2A, ICA, or ZnT8A.
Stimulated C-peptide of ≥ 0.2 pmol/mL measured during MMTT conducted at least 21 days from diagnosis of diabetes.
Participants ≥ 18 years old to have body weight ≥ 35 kg and ≤ 130kg.
Participants \< 18 years old to have body weight \> 5th and \<98th percentile for age and sex.
Willing to comply with intensive diabetes management.
All CMV and/or EBV seronegative participants must be CMV and EBV PCR negative within 30 days of randomization and may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.
All CMV seropositive participants must be CMV PCR negative and all EBV seropositive participants must have a EBV PCR viral load \< 2,000 IU/mL within 30 days of randomization. All participants may not have had signs or symptoms of a CMV or EBV-compatible illness lasting longer than 7 days within 30 days of randomization.
Must meet "TrialNet Eligibility Minimum Immunization Recommendations" found in Appendix A of the MOO.
Be at least 4 weeks from last live vaccination prior to randomization.
Participants that are not already immunized against the current year's influenza are required to receive non-live influenza vaccination at least 2 weeks prior to randomization when vaccine for the current or upcoming flu season is available.
Be willing to forgo vaccines (other than killed influenza and COVID-19) during the treatment phase and the 3 months after study drug treatment period.
If a female participant with reproductive potential, must be willing to avoid pregnancy (abstinence or highly effective contraceptive method) through the completion of the study and undergo pregnancy testing prior to each study visit.
Males of reproductive age must use an adequate contraceptive method during the treatment phase and for 3 months following the last dose of study drug.
Exclusion
One or more screening laboratory values as stated
Neutrophils \< 1,500 /μL
Lymphocytes \< 800 /μL
Platelets \< 100,000 /μL
Hemoglobin \< 6.2 mmol/L (10.0 g/dL)
Eosinophils \> 1,000 /μL
Potassium \> 5.5 mmol/L or \< 3.0 mmol/L
Sodium \> 150 mmol/L or \< 130 mmol/L
Estimated Glomerular Filtration Rate (eGFR) \< 60 mL/min/1.73m2
AST or ALT or ALP \> 2 times the upper limit of normal based on lab reference range
Total Bilirubin ≥ 1.5 times upper limit of normal unless diagnosed with Gilbert's syndrome
Serum creatinine \> 2 times the upper limit of normal
Current or ongoing use of non-insulin pharmaceuticals that affect glycemia within 7 days of the screening visit or any prohibited concomitant medication as listed in section 3.7.
Concurrent treatment with systemic immunosuppressive agents (including biologics or steroids) - intranasal and inhaled corticosteroids are permitted as well as eye and ear drops containing corticosteroids.
Have active signs or symptoms of acute infection at the time of randomization.
Active acute or chronic infection requiring medical treatment (antibiotics, antiviral, antifungal) within 4 weeks of baseline visit unless approved by the Infectious Disease Committee.
Have evidence of prior or current tuberculosis infection as assessed by Purified Protein Derivative (PPD), interferon gamma release assay (IGRA) or by history.
Any present malignancies or history of malignancy within the past 5 years, other than a successfully treated nonmelanoma skin cancer.
Be currently pregnant or lactating or anticipate becoming pregnant during the study.
History of severe cardiac disease (i.e. myocardial infarction, unstable ischemic heart disease, cerebrovascular accident, stroke, stage 3 or 4 heart failure).
Have evidence of current or past HIV or Hepatitis B infection.
Have evidence of active Hepatitis C infection.
History of organ allograft.
Hypersensitivity to IL-2, PEG, or any components of the active drug.
Had major surgery within 12 weeks before the screening visit or anticipates requiring major surgery during the study.
Has any autoimmune disease other than T1D, stable thyroid, stable asthma, inactive Graves' disease or celiac disease (e.g., rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, multiple sclerosis, systemic lupus erythematous) or has any other disease that may be affected by immunotherapy.
Screening 12-lead electrocardiogram (ECG) with findings suggestive/indicative of acute ischemia, clinically important heart disease or clinically important arrhythmias.
Current or history thrombotic events within six months prior to randomization
Known or untreated clinically significant hyperthyroidism or hypothyroidism
Prior treatment within 12 months of randomization with an immune modulating/immune depleting agents, such as teplizumab (TZield), thymoglobulin (ATG) or rituximab.
Prior treatment within 6 months of randomization with a metabolic therapy intended to alter the disease course of T1D (e.g. teplizumab).
Has significant and uncontrolled disease/condition in the investigator's opinion that may adversely affect study participation or may compromise the study results or increase participant risk.
What this trial measures
- The area under the stimulated C-peptide curve (AUC) Y_MAUC.12 Months
The primary outcome of each participant is the mean area under the stimulated C-peptide curve (AUC) over the 2-hour mixed meal glucose tolerance test conducted at the 12-month visit in nmol/L, denoted as Y\_MAUC.