A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)

NCT ID: NCT06548100

Last Updated: 2025-10-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2026-11-03

Brief Summary

This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.

The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin.

The study is looking at several other research questions, including:

• What side effects may happen from taking mibavademab
• How much mibavademab is in the blood at different times
• Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)

Conditions

Generalized Lipodystrophy

Study Design

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

Study Groups

mibavademab

Patients switching from at least 6 months of therapy with metreleptin to mibavademab.

Group Type: EXPERIMENTAL

mibavademab

Intervention Type: DRUG

Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection

Interventions

mibavademab

Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection

Intervention Type: DRUG

Other Intervention Names

REGN4461

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines

2. Treatment with metreleptin for ≥6 months at time of screening at a stable dose, defined as no change in dose within the last 3 months prior to screening

3. Generally stable diet (based on participant's recall) and stable medication regimen for diabetes and/or dyslipidemia (in addition to metreleptin), for the last 3 months prior to screening

4. Willing and able to comply with clinic visits and study-related procedures. Participants who are unable/unwilling to self-inject, but are willing to have a capable caregiver inject, are considered eligible

5. Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting triglycerides from at least 6 months prior to screening, as defined in the protocol

Exclusion Criteria

1. Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit

2. Current chronic treatment with high-dose corticosteroids, as defined in the protocol

3. Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit except for fully treated basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus

4. Estimated glomerular filtration rate (GFR) of <30 mL/min/1.73 m^2 based on chronic kidney disease epidemiology collaboration (CKD-EPI)/Schwartz equation at screening. Assessment can be repeated once

5. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure, or intracardiac device placement within 3 months before the screening visit, as defined in the protocol

6. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study, 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

Locations

National Institutes of Health

Bethesda, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

2024-513202-54-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

R4461-GLD-2284

Identifier Type: -

Identifier Source: org_study_id