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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study ID
NCT07142252
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
8 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 14, 2026
Status verified
Jun 2026
Primary completion
May 25, 2028
Completion
May 25, 2028

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: rezpegaldesleukin
    Participants assigned to this arm will receive Rezpegaldesleukin
  • Placebo Comparator: Placebo
    Participants assigned to this arm will received placebo.

Primary Outcome Measure

The area under the stimulated C-peptide curve (AUC) Y_MAUC. [ Time Frame: 12 Months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of PittsburghPittsburghPennsylvania15224
Carly Shelleby, RN, BS
[email protected]
412-692-7241
Kelli Delallo, RN, BSN
[email protected]
412-692-5210
Ingrid Libman, MD, PhD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37232
Kimberly Rainer, RN
[email protected]
615-936-8638
Daniel Moore, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Pittsburgh· Pittsburgh, PAVanderbilt University· Nashville, TN

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