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Brivekimig for preservation of β-cell function in recently diagnosed type 1 diabetes
NCT06812988Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Feb 2025
- Primary completion
- Apr 2027
- Countries
- 8
- Sponsor
- Sanofi
- Modality
- Nanobodies (VHH), Monoclonal Antibodies
- Drugs
- brivekimig
- Conditions
- type 1 diabetes mellitus (T1D)
01
Overview
Phase 2, randomised, double-blind trial of brivekimig in type 1 diabetes mellitus (T1D), sponsored by Sanofi. Primary endpoint: Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test stimulated C-peptide concentration. Started Feb 2025; status: active, not recruiting.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Adults (18-35) and adolescents (12-21) with recently diagnosed Stage 3 type 1 diabetes (within 90 days of insulin initiation), positive for at least one T1D autoantibody, and having random C-peptide levels ≥0.2 nmol/L.
04
Endpoints
Primary
Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test stimulated C-peptide concentration
Secondary
Change from baseline to Week 52 in mean 2-hour mixed meal tolerance test stimulated C-peptide concentration
Participant remaining C-peptide positive at Week 26 and Week 52
Time in range (70-180 mg/dL) at Week 26 and Week 52
Change from baseline to Week 26 and Week 52 in insulin dose
Change from baseline to Week 26 and Week 52 in glycated hemoglobin A1c level
Participant having HbA1c ≤6.5% and ≤0.25 IU/kg/day of exogenous insulin required at Week 26 and Week 52
Incidence of treatment emergent adverse events, serious adverse events, adverse events of special interest and TEAEs leading to treatment discontinuation
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