RecruitingPhase 2NCT06964087

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

A 48-week Phase 2 Multicenter Controlled Pharmacokinetic and Pilot Efficacy Trial of Subcutaneous OPT101 in Patients With Recent Onset Type 1 Diabetes Mellitus

Sponsor

Op-T LLC

Enrollment

72 participants

Start Date

Apr 10, 2026

Study Type

INTERVENTIONAL

Conditions

Type I Diabetes

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.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called OPT101 and OPT101 Placebo to Match (PTM) for people with type i diabetes. The study is currently recruiting participants at 5 locations. People eligible for this study include aged 18 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOPT101

Subcutaneous injection.

OTHEROPT101 Placebo to Match (PTM)

5% Dextrose (w/v)

Locations(5)

University of Alabama at Birmingham - Department of Medicina

Birmingham, Alabama, United States

Diablo Clinical Research Center

Walnut Creek, California, United States

Barbara Davis Center - University of Colorado Anschuttz Medical Campus

Aurora, Colorado, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Rainier Clinical Research Center

Renton, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06964087

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