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

NCT06964087 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

  • Type I Diabetes

Interventions

DRUG

OPT101

Subcutaneous injection.

OTHER

OPT101 Placebo to Match (PTM)

5% Dextrose (w/v)

Sponsors & Collaborators

  • Op-T LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2026-05-31
Completion
2028-08-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964087 on ClinicalTrials.gov