Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus (NCT07142252)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Barbara Davis Center for Diabetes — Aurora, Colorado
Age range: 8 Years to 45 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (10 Sites)
- Barbara Davis Center for Diabetes — Aurora, Colorado
- University of Florida — Gainesville, Florida
- University of Miami — Miami, Florida
- Joslin Diabetes Center — Boston, Massachusetts
- Columbia University — New York, New York
- University of Pittsburgh — Pittsburgh, Pennsylvania
- Vanderbilt University — Nashville, Tennessee
- University of Utah — Salt Lake City, Utah
- Benaroya Research Institute — Seattle, Washington
- University of British Columbia — Vancouver, British Columbia
📞 Contact the Study Coordinator
Phone: (813) 396-9234
Email: Jessica.Conaty@epi.usf.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Type 1 Diabetes Mellitus
- Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) — Chicago, Illinois
- Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes — Orange, California
- A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation — Chicago, Illinois
- Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus — Walnut Creek, California
- Triple Therapy in T1DM — Williamsville, New York
- Clinical Phase II/III Trial of Ustekinumab to Treat Type 1 Diabetes (UST1D2) — Toronto, British Columbia
Explore by condition: All Type 1 Diabetes Mellitus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.