Clinical trialNCT07142252RecruitingPhase 2Interventional

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

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment66Type 1 Diabetes Mellitus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Daniel Moore, MD
Type 1 Diabetes TrialNet
Study Chair
clinicaltrials.gov ↗
Kevan Herold, MD
Type 1 Diabetes TrialNet Chairman
Study Director
clinicaltrials.gov ↗
Megan Levings, PhD
Type 1 Diabetes TrialNet
Study Chair
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada

University of British Columbia
Vancouver, British Columbia, Canada
Megan Levings, PhD
Not, yet, recruiting

United States

Barbara Davis Center for Diabetes
Aurora, Colorado, United States
Peter Gottlieb, MD
Recruiting
University of Florida
Gainesville, Florida, United States
Timothy Foster, MD
Recruiting
University of Miami
Miami, Florida, United States
David Baidal, MD
Recruiting
Joslin Diabetes Center
Boston, Massachusetts, United States
Jason Gaglia, MD
Recruiting
Columbia University
New York, New York, United States
Jacqueline Lonier, MD
Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Ingrid Libman, MD, PhD
Recruiting
Vanderbilt University
Nashville, Tennessee, United States
Daniel Moore, MD
Recruiting
University of Utah
Salt Lake City, Utah, United States
Zoe Raleigh, MD
Recruiting
Benaroya Research Institute
Seattle, Washington, United States
Kurt Griffin, MD
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

PlaceboRezpegaldesleukin

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 14 May 2026
Primary completion: 25 May 2028
Completion: 25 May 2028
Last update posted: 18 Jun 2026
Registered enrollment: 66
Registry id: NCT07142252

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.