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RECRUITING
NCT06964087
PHASE2

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

Sponsor: Op-T LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-04-10

Completion Date

2028-08-19

Last Updated

2026-04-06

Healthy Volunteers

No

Conditions

Interventions

DRUG

OPT101

Subcutaneous injection.

OTHER

OPT101 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