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A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults | Clinical Trials | Clareo Health

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A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults

An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene

NCT07220772•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called monogenic obesity. Monogenic obesity is caused by a change in the leptin gene that keeps it from working properly. This causes the body to not be able to feel full or control feelings of hunger. The aim of the study is to see how well mibavademab controls the body weight and how safe it is. The study is looking at several other research questions, including: * How much mibavademab is in the blood at different times * Whether the body makes proteins called antibodies against mibavademab (which could stop mibavademab from working as well or could lead to side effects) * What side effects may happen from taking mibavademab

Eligibility

Age

2 - No limit years

Sex

ALL

Healthy Volunteers

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

Exclusion Criteria

•1. Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening
•2. History of bariatric surgery within approximately the past 12 months of study screening
•3. History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening
•4. History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene
•5. History of schizophrenia, bipolar disorder, or other mental illness that, in the opinion of the investigator, might pose a safety risk to participation in a clinical study of an investigational drug
•6. Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) during screening or baseline, or any lifetime history of a suicide attempt, or any lifetime history of suicidal behavior, including ideation
•7. Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening
•8. Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol

Locations (1)

ULM University Medical Centre

Ulm, Germany

Key Dates

Start Date

February 9, 2026

Primary Completion Date

June 18, 2027

Completion Date

April 21, 2028

Last Updated

March 10, 2026

Enrollment

ESTIMATED participants

Conditions

Monogenic Obesity

Interventions

Mibavademab

DRUG

Contacts

Clinical Trials Administrator

CONTACT

844-734-6643 clinicaltrials@regeneron.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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