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

Part of paid clinical trials in Aurora, Colorado.

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

First listed
Aug 26, 2025
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 (9)

FacilityCityStateZIPSite coordinators
Barbara Davis Center for DiabetesAuroraColorado80045
Elizabeth Smith, RN, BSN
[email protected]
720-346-1034
Peter Gottlieb, MD (PRINCIPAL_INVESTIGATOR)
University of FloridaGainesvilleFlorida32610
Magali Jorand-Fletcher
[email protected]
352-273-5121
Timothy Foster, MD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Jhanvi Paraskumar Doshi
[email protected]
305-243-3306
David Baidal, MD (PRINCIPAL_INVESTIGATOR)
Joslin Diabetes CenterBostonMassachusetts02115
Samantha Kateman
[email protected]
617-975-8269
Jason Gaglia, MD (PRINCIPAL_INVESTIGATOR)
Columbia UniversityNew YorkNew York10032
Amy Doytchinov, BSN, RN
[email protected]
212-851-5505
Jacqueline Lonier, MD (PRINCIPAL_INVESTIGATOR)
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
Brenna Hammel, RN, BSN
[email protected]
615-936-5774
Daniel Moore, MD (PRINCIPAL_INVESTIGATOR)
University of UtahSalt Lake CityUtah84113
Elisa Anguiano
[email protected]
801-213-7768
Zoe Raleigh, MD (PRINCIPAL_INVESTIGATOR)
Benaroya Research InstituteSeattleWashington98101
Megan Olson
[email protected]
206-287-1086
Kurt Griffin, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Barbara Davis Center for Diabetes· Aurora, COUniversity of Florida· Gainesville, FLUniversity of Miami· Miami, FLJoslin Diabetes Center· Boston, MAColumbia University· New York, NYUniversity of Pittsburgh· Pittsburgh, PA

Related Studies