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

NCT07220772 | Recruiting Phase 3 FDA Drug

• 2 other identifiers: R4461-MOB-24712024-518674-14-00
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Keywords

Biallelic loss of function variants of the LEP gene mutations; Leptin deficiency

Outcome Measures

Primary Outcomes (1)

• Percent change in Body Mass Index (BMI)

  Baseline to Week 24

Secondary Outcomes (17)

• 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

• Absolute change in body weight

  Baseline, Through Week 52

• Change in waist circumference

  Baseline, Through Week 52

Study Arms (1)

Mibavademab

EXPERIMENTAL

Drug: Mibavademab

Interventions

Mibavademab DRUG

Administered as per the protocol

Also known as: REGN4461

Mibavademab

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit
• Has class ≥2 obesity at screening and at baseline, as defined in the protocol

You may not qualify if:

• Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening
• History of bariatric surgery within approximately the past 12 months of study screening
• History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening
• History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene
• 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
• 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
• Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening
• Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (1)

ULM University Medical Centre

Ulm, 89075, Germany

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2025
• First Posted: October 24, 2025
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 18, 2027
• Study Completion (Estimated): April 21, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

DE (1)