drugset / Trial / NCT06964087

Pharmacokinetic and Early Efficacy of OPT101 in Patients With Type 1 Diabetes Mellitus

NCT06964087 ↗

Phase 2 Recruiting 72 enrolled Op-T LLC
RandomizedSequentialTriple-blindTreatment

Summary

This study will examine the safety of three times weekly SC injections of OPT101 at each of three dose levels over two weeks as well as one year of treatment with SC OPT101 or placebo to match at a single dose level.

Timeline

Start
2026-04-10
Primary completion
2026-05-31
Completion
2028-08-19

Drugs

EvaluationDrugModalityDoseRoute
Subject OPT101 Peptide 1 mg/kg Subcutaneous
Subject OPT101 Peptide 1.5 mg/kg Subcutaneous
Subject OPT101 Peptide 2 mg/kg Subcutaneous