Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus (NCT07142252) | Clinical Trial Compass
RecruitingPhase 2
Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus
United States, Canada66 participantsStarted 2026-05-14
Plain-language 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.
Who can participate
Age range
8 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 las…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a drug called rezpegaldesleukin in people with new onset Type 1 diabetes — can you explain what 'new onset' means here and whether the timing of my diagnosis would even make this worth discussing as an option?
2The trial is measuring something called stimulated C-peptide AUC, which I understand reflects how much insulin my pancreas is still making — can you tell me what my current C-peptide levels look like and why that matters for understanding a trial like this?
3Since this is a Phase 2 trial, what does that mean for how much is already known about whether this drug is safe and effective, and how would you weigh that uncertainty against my current standard treatment plan?
4Rezpegaldesleukin appears to work on the immune system — given that Type 1 diabetes is an autoimmune condition, what are the potential risks of a drug that modulates immune responses, and are there any specific risks I should be aware of based on my health history?
5If I were to discuss enrolling in this trial with you, how would participation affect my regular diabetes management — for example, would my insulin regimen change, and how often would I need to come in for monitoring??
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The area under the stimulated C-peptide curve (AUC) Y_MAUC.
Timeframe: 12 Months
Trial details
NCT IDNCT07142252
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)