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Mibavademab

Phase 3

Monogenic Obesity | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Mar 10, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment4
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07220772A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and AdultsPHASE3 RECRUITING 4Feb 9, 2026Apr 21, 2028Mar 10, 20261 Germany
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Study Endpoints
Primary Endpoints
Percent change in Body Mass Index (BMI)
Baseline to Week 24
Secondary Endpoints
Percent change in BMI
Baseline to Week 52
Absolute change in BMI
Baseline, Through Week 52
Percent change in body weight
Baseline, Through Week 52
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MibavademabEXPERIMENTAL -
Interventions
NameTypeDescription
MibavademabDRUGAdministered as per the protocol
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Eligibility Criteria
Age Range2 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: 1. Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit 2. Has class ≥2 obesity at screening and at baseline, as defined in the protocol Key Exclusion Criteria: 1. Unwilling or unable to provide, or have the tre...

Countries:Germany
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07220772primaryCompletionDate: changed
LOWMay 24, 2026NCT07220772studyFirstPostDate: changed