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Mibavademab

Phase 3

Monogenic Obesity | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Aug 18, 2026

Target and mechanism

Molecular targetLEPR
Target classAgonist
ModalitySmall molecule
ChEMBLCHEMBL4650509

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment4

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
COMPLETED9 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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PHASE3COMPLETED
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 Sites5

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 StatesBrazilFranceGermany
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Recent Changes (Last 90 Days)

MEDIUMAug 29, 2026NCT06548100TRIAL_REMOVED: changed
MEDIUMAug 29, 2026NCT06548100TRIAL_REMOVED: changed
MEDIUMAug 29, 2026NCT06548100TRIAL_REMOVED: changed
LOWAug 18, 2026NCT07220785lastUpdatePostDate: changed
LOWAug 18, 2026NCT07220785lastUpdatePostDate: changed
LOWAug 5, 2026NCT07220785lastUpdatePostDate: changed
HIGHJul 29, 2026NCT06548100Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHJul 29, 2026NCT06548100Status: ACTIVE_NOT_RECRUITING → COMPLETED
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

Frequently asked questions about Mibavademab

What is Mibavademab used for?

Mibavademab is an investigational drug being developed for monogenic obesity, functional hypothalamic amenorrhea (FHA), and generalized lipodystrophy. It is being studied in clinical trials for these endocrine conditions.

What does Mibavademab target?

Mibavademab targets the leptin receptor (LEPR) and acts as an agonist. It is designed to activate this receptor, which plays a role in regulating body weight and metabolism.

Who makes Mibavademab?

Mibavademab is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol REGN.

What phase is Mibavademab in?

Mibavademab is in Phase 2 clinical development. It is currently being studied in a Phase 2 trial for functional hypothalamic amenorrhea, while other trials for generalized lipodystrophy and monogenic obesity are in Phase 3.

What clinical trials is Mibavademab in?

Mibavademab is being evaluated in several trials. NCT07235917 is a Phase 2 study in women with functional hypothalamic amenorrhea. NCT07220772 and NCT07220785 are Phase 3 trials for monogenic obesity and generalized lipodystrophy, respectively. NCT06548100 is a completed Phase 3 study in generalized lipodystrophy.

Is Mibavademab the same as metreleptin?

Mibavademab is not the same as metreleptin. It is a separate investigational drug being studied as a potential treatment for generalized lipodystrophy, with some trials evaluating patients switching from metreleptin to mibavademab.