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Brivekimig

Phase 2

Type 1 Diabetes Mellitus | Small molecule | Metabolic |Sanofi|Last Updated: Mar 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment84
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06812988Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® MoleculePHASE2 ACTIVE NOT_RECRUITING 84 — — Feb 28, 2025Apr 29, 2027Mar 13, 202624 United States, Argentina +6
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Study Endpoints
Primary Endpoints
Change from baseline to Week 26 in mean 2-hour mixed meal tolerance test (MMTT) stimulated C-peptide concentration
From Baseline to Week 26

Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)

Secondary Endpoints
Change from baseline to Week 52 in mean 2-hour MMTT stimulated Cpeptide concentration
From Baseline to Week 52
Participant remaining C-peptide positive at Week 26 and Week 52
Week 26 and Week 52
Time in range (TIR) (70-180 mg/dL) at Week 26 and Week 52
Week 26 and Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BrivekimigEXPERIMENTALParticipants will receive subcutaneous injection of brivekimig.
PlaceboPLACEBO_COMPARATORParticipants will receive subcutaneous injection of matching placebo.
Interventions
NameTypeDescription
BrivekimigDRUGPharmaceutical form: Solution Route of administration: Subcutaneous injection
PlaceboDRUGPharmaceutical form: Solution Route of administration: Subcutaneous injection
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Eligibility Criteria
Age Range12 Years — 35 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: 1. Participant must be 18 to 35 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part A. Participant must be 12 to 21 y.o. inclusive, at the time of signing the informed consent in order to be enrolled in Part B. 2. Participants who meet the...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileIsraelSaudi Arabia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06812988primaryCompletionDate: changed
LOWMay 24, 2026NCT06812988studyFirstPostDate: changed