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Type 1 Diabetes MellitusPhase 2NCT07142252

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

A Phase 2 study testing Rezpegaldesleukin in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 8 to 45 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Rezpegaldesleukin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
15 sitesin 2 countries
Study dates
14 May 2026to 25 May 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

15 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Jessica Conaty contact

813-396-9234

Jessica.Conaty@epi.usf.edu

15 sites in 2 countries

United States14 sites, 14 recruiting

  • Barbara Davis Center for Diabetes

    Aurora, Colorado, 80045

    Elizabeth Smith, RN, BSN, 720-346-1034, elizabeth.h.smith@cuanschutz.edu

    Peter Gottlieb, MD

    Recruiting

  • Joslin Diabetes Center

    Boston, Massachusetts, 02115

    Samantha Kateman, 617-975-8269, skateman@joslin.harvard.edu

    Jason Gaglia, MD

    Recruiting

  • University of Florida

    Gainesville, Florida, 32610

    Magali Jorand-Fletcher, 352-273-5121, magali20@ufl.edu

    Timothy Foster, MD

    Recruiting

  • Indiana University-Riley Hospital for Children

    Indianapolis, Indiana, 46202

    Maria Spall, 1-866-230-8486, malnicho@iu.edu

    Linda DiMeglio, MD

    Recruiting

  • University of Miami

    Miami, Florida, 33136

    Jhanvi Paraskumar Doshi, 305-243-3306, jxd4468@med.miami.edu

    David Baidal, MD

    Recruiting

  • University of Minnesota

    Minneapolis, Minnesota, 55455

    Beth Pappenfus, (612) 624-2922, papp0086@umn.edu

    Toni Moran, MD

    Recruiting

  • Vanderbilt University

    Nashville, Tennessee, 37232

    Brenna Hammel, RN, BSN, 615-936-5774, brenna.hammel@vumc.org

    Daniel Moore, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06520

    Anagha Babu, 203-737-7650, anagha.babu@yale.edu

    Jennifer Sherr, MD

    Recruiting

  • Columbia University

    New York, New York, 10032

    Amy Doytchinov, BSN, RN, 212-851-5505, as8064@cumc.columbia.edu

    Jacqueline Lonier, MD

    Recruiting

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15224

    Carly Shelleby, RN, BS, 412-692-7241, shellebyc@upmc.edu

    Kelli Delallo, RN, BSN, 412-692-5210, Kelli.Delallo@chp.edu

    Recruiting

  • University of Utah

    Salt Lake City, Utah, 84113

    Elisa Anguiano, 801-213-7768, elisa.anguiano@hsc.utah.edu

    Zoe Raleigh, MD

    Recruiting

  • University of California San Francisco

    San Francisco, California, 94158

    Rebecca Wesch, 415-476-5984, rebecca.wesch@ucsf.edu

    Stephen Gitelman, MD

    Recruiting

  • Benaroya Research Institute

    Seattle, Washington, 98101

    Megan Olson, 206-287-1086, molson@benaroyaresearch.org

    Kurt Griffin, MD

    Recruiting

  • USF Diabetes Center

    Tampa, Florida, 33612

    Elizabeth Dunn, 813-974-4886, eadunn3@usf.edu

    Henry Rodriguez, MD

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • University of British Columbia

    Vancouver, British Columbia, V5Z4H4

    Megan Levings, PhD, 604-875-2000 ext. 4686, mlevings@bcchr.ca

    Megan Levings, PhD

    Not yet recruiting

Other trials in Canada

About this study

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.

Read the 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.

Being tested
Rezpegaldesleukin, Placebo
Keywords
TrialNet, T1D
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RezpegaldesleukinDrug

    Also called NKTR-358

    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.

  • PlaceboDrug

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

Study groups in NCT07142252
Study groupRoleWhat they receive
rezpegaldesleukinExperimentalParticipants assigned to this arm will receive Rezpegaldesleukin
Receives: Drug: Rezpegaldesleukin
PlaceboPlacebo comparatorParticipants assigned to this arm will received placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The area under the stimulated C-peptide curve (AUC) Y_MAUC.

    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.

    Measured: 12 Months

Secondary outcomes (6)

  1. Change of MMTT C-peptide mean AUC

    This measure will investigate the change of MMTT C-peptide mean AUC between the placebo and rezpegaldesleukin groups applying ANCOVA models and longitudinal mixed-effects models.

    Measured: From enrollment to end of the study at 12 months

  2. Adverse Events

    Number of adverse events and severity reported over the course of the study

    Measured: From enrollment till the end of the study at 12 months

  3. Total Daily Insulin Dose per kilogram

    Total Daily insulin Dose per kilogram as collected every 3 months once enrolled in the study to 1 year post enrollment.

    Measured: From enrollment and every 3 months to end of study at 12 months.

  4. Change in Quantitative Response (QR) in placebo and treatment groups over time

    Investigate the effect on beta cell function at 6 and 12 months in comparison to both contemporaneous placebo-treated participants and historical model-adjusted placebo controls as defined by the Quantitative Response (QR).

    Measured: From enrollment to end of treatment at 6 months and end of study at 12 months.

  5. Change of MMTT Glucose mean AUC

    This measure will investigate the change of MMTT Glucose mean AUC between the placebo and rezpegaldesleukin groups applying ANCOVA models and longitudinal mixed-effects models.

    Measured: From enrollment to end of study at 12 months.

  6. Change of HbA1c

    This measure will investigate the change of HbA1c between the placebo and rezpegaldesleukin groups applying ANCOVA models and longitudinal mixed-effects models.

    Measured: From enrollment to end of study at 12 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Aug 2025
  2. Study start14 May 2026
  3. Primary completion25 May 2028 (estimated)
  4. Study completion25 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This trial will enroll 66 participants who will be randomly assigned in a 2:1 allocation to the following treatment arms: * Approximately 44 participants will be randomized to rezpegaldesleukin * Approximately 22 participants will be randomized to placebo.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07142252
Sponsor's protocol ID
TN36 Rezpeg in New Onset
Status last verified
Sep 2026
First submitted
19 Aug 2025
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Data will be available at the NIDDK Central Repository

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Rezpegaldesleukin in people with Type 1 Diabetes Mellitus, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jessica Conaty (813-396-9234, Jessica.Conaty@epi.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The area under the stimulated C-peptide curve (AUC) Y_MAUC. (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07142252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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