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

NCT ID: NCT07220772

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-19
• Study Completion Date: 2028-03-30

Brief 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

Conditions

Monogenic Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mibavademab

Group Type: EXPERIMENTAL

Mibavademab

Intervention Type: DRUG

Administered as per the protocol

Interventions

Mibavademab

Administered as per the protocol

Intervention Type: DRUG

Other Intervention Names

REGN4461

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Central Contacts

Clinical Trials Administrator

Role: CONTACT

clinicaltrials@regeneron.com

844-734-6643

Other Identifiers

2024-518674-14-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

R4461-MOB-2471

Identifier Type: -

Identifier Source: org_study_id