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NCT00385697COMPLETEDanonymous

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

Source record

MacroGenics

Phase

Source record

Phase 2/3

Modality

AI-normalized

monoclonal antibody

Target

AI-normalized

Type 1 Diabetes Mellitus

Indication / condition

AI-normalized

Type 1 Diabetes Mellitus

Intervention

Source record

Teplizumab, Placebo

Source & freshness

Source record

NCT ID

NCT00385697

Original source

ClinicalTrials.gov

Source last updated

Dec 05, 2023

Ingested at

May 31, 2026

Internal sync

Jun 05, 2026

Model version

trialsignal-ai-v1

Normalized confidence

88%

Validation status

validated

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View original source fields

NCT ID

NCT00385697

Title

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

MacroGenics

Status

COMPLETED

Phase

Phase 2/3

Condition raw

Type 1 Diabetes Mellitus

Condition normalized

Type 1 Diabetes Mellitus

Modality raw

Type 1 Diabetes Mellitus

Modality normalized

monoclonal antibody

Target raw

Type 1 Diabetes Mellitus

Target normalized

Type 1 Diabetes Mellitus

Interventions

Teplizumab, Placebo

Public preview

Source record

The Protégé Study evaluated MGA031 (teplizumab), a humanized anti-CD3 monoclonal antibody, for its efficacy and safety in reducing insulin requirements and improving blood sugar levels in children and adults with recent-onset type 1 diabetes. Conducted by MacroGenics in collaboration with Eli Lilly, the trial enrolled 554 participants across multiple centers.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

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

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT00385697

Status

COMPLETED

Phase

Phase 2/3

Sponsor

MacroGenics

Executive brief

Investment-Ready Snapshot

The Protégé Study evaluated MGA031 (teplizumab), a humanized anti-CD3 monoclonal antibody, for its efficacy and safety in reducing insulin requirements and improving blood sugar levels in children and adults with recent-onset type 1 diabetes. Conducted by MacroGenics in collaboration with Eli Lilly, the trial enrolled 554 participants across multiple centers.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedDec 05, 2023
Internal syncJun 05, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT00385697

Indication

Type 1 Diabetes Mellitus

Modality

monoclonal antibody

Target

Type 1 Diabetes Mellitus

Intervention

Teplizumab, Placebo

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.