A Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Combination With Teplizumab in Participants With Recent-onset Diagnosed Type 1 Diabetes (T1D)

ClinicalTrials.gov ID: NCT03751007

Public ClinicalTrials.gov record NCT03751007. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:31 PM EDT

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Official title

A Prospective, Multi-center, Phase 1b/2a Study to Assess the Safety and Tolerability of Different Doses of AG019 Administered Alone or in Association With Teplizumab in Patients With Clinical Recent-onset Type 1 Diabetes Mellitus (T1D)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to assess the safety and tolerability of different doses of AG019 administered alone or in combination with teplizumab in participants with recent-onset type 1 diabetes (T1D).

Study identification

NCT ID: NCT03751007
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1, Phase 2
Lead sponsor: Precigen Actobio T1D, LLC; Industry
Enrollment: 45 participants

Conditions and interventions

Conditions

Diabetes type1

Interventions

Biological · Drug

Eligibility (public fields only)

Age range: 12 Years to 40 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 24, 2018 (Actual)
Primary completion: Oct 13, 2021 (Actual)
Completion: Oct 13, 2021 (Actual)
Last update posted: Feb 1, 2023

2018 – 2021

United States locations

U.S. sites: 15
U.S. states: 12
U.S. cities: 15

Facility	City	State	ZIP	Site status
University of Alabama, Birmingham	Birmingham	Alabama	35294	—
University of California, San Francisco	San Francisco	California	94158	—
Coastal Metabolic Research Centre	Ventura	California	93003	—
University of Colorado	Aurora	Colorado	80045	—
Yale Center for Clinical Investigation	New Haven	Connecticut	06519	—
University of Miami	Miami	Florida	33136	—
University of South Florida	Tampa	Florida	33612	—
Barry J Reiner, MD, LLC	Baltimore	Maryland	21229	—
University of Minnesota Health	Minneapolis	Minnesota	55454	—
University of Missouri-Kansas City School of Medicine	Kansas City	Missouri	64108	—
Sanford Children's Specialty Clinic	Sioux Falls	South Dakota	57117	—
University Diabetes and Endocrine Consultants	Chattanooga	Tennessee	37411	—
Texas Diabetes & Endocrinology, P.A.	Austin	Texas	78749	—
Research Institute of Dallas	Dallas	Texas	75231	—
Benaroya Research Institute	Seattle	Washington	98101	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03751007, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Feb 1, 2023 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03751007 live on ClinicalTrials.gov.

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