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mibavademab

Phase 3

Generalized Lipodystrophy | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Jul 14, 2026

Success Probability
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment37
FDA Designations
No designations recorded
Clinical trial landscape

mibavademab · 4 trials · 3 indications

Phase 3 3Phase 2 1
NCT07220785Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized LipodystrophyGeneralized Lipodystrophy
RECRUITING28 Analytics
NCT07220772A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and AdultsMonogenic Obesity
RECRUITING4 Analytics
NCT06548100A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)Generalized Lipodystrophy
ACTIVE NOT_RECRUITING9 Analytics
PHASE3RECRUITING
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
NCT0722078528
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PHASE3RECRUITING
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Monogenic Obesity
NCT072207724
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PHASE3ACTIVE NOT_RECRUITING
A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)
Generalized Lipodystrophy
NCT065481009
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Study Endpoints
Primary Endpoints
Change in Hemoglobin A1c (HbA1c)
Through 36 weeks of exposure to mibavademab

Part A

Percent change in fasting Triglycerides (TG)
Through 36 weeks of exposure to mibavademab

Part A

Occurrence of Treatment Emergent Adverse Events (TEAEs)
Up to 15 months

Part B

Severity of TEAEs
Up to 15 months

Part B

Concentrations of total mibavademab in serum
Up to 15 months

Part B

Percent change in Body Mass Index (BMI)
Baseline to Week 24
Incidence of treatment-emergent adverse events (TEAEs)
Up to week 68
Change from the highest serum estradiol observed during a 28-day period
Baseline to month 6
Secondary Endpoints
Change in HbA1c compared to placebo
From baseline to week 20
Change in HbA1c
From baseline to week 52
Percent change in fasting TG compared to placebo
From baseline to week 20
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Part A: Arm AEXPERIMENTAL -
Part A: Arm BEXPERIMENTAL -
Part A: Arm CEXPERIMENTAL -
Part A: Arm DPLACEBO_COMPARATOR -
Part BEXPERIMENTAL -
MibavademabEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
MibavademabDRUGAdministered as per the protocol
PlaceboDRUGAdministered as per the protocol
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Eligibility Criteria
Age Range2 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria: 1\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines For Part A only: 1. Participants ≥2 years of age at screening 2. At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screenin...

Countries:United StatesFranceGermany
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Recent Changes (Last 90 Days)
LOWJul 14, 2026NCT07235917lastUpdatePostDate: changed
LOWJul 14, 2026NCT07235917lastUpdatePostDate: changed
LOWJul 13, 2026NCT07220785lastUpdatePostDate: changed
LOWJul 13, 2026NCT07220785lastUpdatePostDate: changed
LOWJun 18, 2026NCT07235917lastUpdatePostDate: changed
LOWJun 18, 2026NCT07235917lastUpdatePostDate: changed
LOWJun 18, 2026NCT07235917lastUpdatePostDate: changed
LOWJun 18, 2026NCT07235917lastUpdatePostDate: changed
LOWMay 26, 2026NCT07220785Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT07235917primaryCompletionDate: changed
LOWMay 26, 2026NCT07220772primaryCompletionDate: changed
LOWMay 26, 2026NCT06548100primaryCompletionDate: changed
LOWMay 24, 2026NCT07235917studyFirstPostDate: changed
LOWMay 24, 2026NCT07220772studyFirstPostDate: changed
LOWMay 24, 2026NCT07220785studyFirstPostDate: changed
LOWMay 24, 2026NCT06548100studyFirstPostDate: changed