NCT06057454

R-5280 in Newly Diagnosed Patients With Type 1 Diabetes

Evaluating the Safety and Tolerability of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Rise Therapeutics LLC · Industry
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Evaluating the adverse events and tolerance of R-5280 in Mitigating Type 1 Diabetes in Newly Diagnosed Patients

Detailed description

Double blinded, placebo controlled, Phase 1B study assessing the safety and efficacy of 12 weeks daily administrations of R-5280 in newly diagnosed Type 1 Diabetes adolescents

Conditions

• Type 1 Diabetes
• Type 1 Diabetes (Juvenile Onset)
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DRUG	R-5280	Modified Superior Starch
OTHER	Placebo	Food Grade Starch

Timeline

• Start date: 2023-12-05
• Primary completion: 2025-11-05
• Completion: 2025-11-05
• First posted: 2023-09-28
• Last updated: 2025-11-10

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study