The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm, Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of MGA031, a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus
Sponsor: Eli Lilly and Company
Listed as NCT00385697, this PHASE2/PHASE3 trial focuses on Type 1 Diabetes Mellitus and remains completed. Sponsored by Eli Lilly and Company, it has been updated 9 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
9 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE2/PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE2/PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2/PHASE3
Phase: PHASE2_PHASE3 → PHASE2/PHASE3
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Jan 2024 — Jul 2024 [monthly]
Completed PHASE2_PHASE3
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Apr 2022 — Jan 2024 [monthly]
Completed PHASE2_PHASE3
▶ Show 4 earlier versions
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Jan 2021 — Apr 2022 [monthly]
Completed PHASE2_PHASE3
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE2_PHASE3
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Feb 2017 — Jun 2018 [monthly]
Completed PHASE2_PHASE3
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Jan 2017 — Feb 2017 [monthly]
Completed PHASE2_PHASE3
First recorded
Oct 2006
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Eli Lilly and Company
- MacroGenics
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Ahmedabad, India , Albany, United States , Alcalá de Henares, Spain , Atlanta, United States , Aurora, United States , Bacau, Romania , Bad Oeynhausen, Germany , Badalona, Spain , Baltimore, United States , Bangalore, India and 97 more locations