Clinical Trial

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

Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated April 6, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-04-30; most recent amendment 2026-04-02.
Status change: Active, Not Recruiting → Recruiting 2026-04-02
Status change: Not Yet Recruiting → Active, Not Recruiting 2025-09-09
Trial Details
NCT Number NCT06964087
Lead Sponsor Op-T LLC
Conditions Type I Diabetes
Enrollment 72 participants
Start Date 2026-04-10
Primary Completion 2026-05-31 (estimated)
Study Completion 2028-08-19 (estimated)
Updated on ClinicalTrials.gov 2026-04-06