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Could a new injection help people with New-Onset type 1 diabetes keep making insulin?

NCT ID NCT07142252

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a drug called rezpegaldesleukin in people recently diagnosed with type 1 diabetes (within 100 days). The goal is to see if it can help the body keep producing some insulin, reducing the need for injected insulin. 66 participants will receive either the drug or a placebo every two weeks for 26 weeks, and their insulin production will be measured after 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Rezpegaldesleukin (NKTR-358)
What this could lead to
If it works, this could help people with new-onset type 1 diabetes keep making some of their own insulin, reducing the need for injected insulin.
What could go wrong
This is an early Phase 2 trial with only 66 people, so results may not apply to everyone. The drug may not preserve insulin production better than placebo, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 45 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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. A Only adult participants ≥ 18 years old are permitted to be included in the first 18 enrolled participants in this study. Participants ≥ 12 and \< 18 years of age are only permitted to screen for this study if the safety review of the first 18 adult participants is assessed favorably by the TrialNet DSMB in consultation with Nektar Safety Group. Once an additional 17 participants ages 12 to 45, including at least 9 participants aged 12-17, enroll and complete through the 6-month visit and have the safety review assessed favorably by the TrialNet DSMB in consultation with Nektar Safety Group, then the trial is permitted to screen and enroll the remaining 31 enrollees ≥ 8 and ≤ 45 years old. If data at either juncture do not support expansion into the pediatric ages, the trial will enroll the remaining participants to reach the target sample size with the currently approved age thresholds. See protocol sections 2.5 and 3.5 for additional details. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barbara Davis Center for Diabetes

    RECRUITING

    Aurora, Colorado, 80045, United States

  • Benaroya Research Institute

    RECRUITING

    Seattle, Washington, 98101, United States

  • Columbia University

    RECRUITING

    New York, New York, 10032, United States

  • Indiana University-Riley Hospital for Children

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Joslin Diabetes Center

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • USF Diabetes Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • University of British Columbia

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V5Z4H4, Canada

  • University of California San Francisco

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Florida

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06520, United States

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Other studies related to the condition(s) this trial covers.