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

Last updated: July 28, 2025
Sponsor: Regeneron Pharmaceuticals
Overall Status: Active - Not Recruiting

Phase

3

Condition

Skin Lipomas

Treatment

mibavademab

Clinical Study ID

NCT06548100
R4461-GLD-2284
2024-513202-54-00
  • Ages > 2
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

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

  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 regimenfor diabetes and/or dyslipidemia (in addition to metreleptin), for the last 3 monthsprior 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 acapable caregiver inject, are considered eligible

  5. Willing and able to provide, or have the treating physician provide, values of HbA1cand fasting triglycerides from at least 6 months prior to screening, as defined inthe protocol

Exclusion

Key Exclusion Criteria:

  1. Treatment with over-the-counter or prescription medications for weight loss within 3months 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 visitexcept for fully treated basal cell or squamous epithelial cell carcinomas of theskin 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 chronickidney 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, unstableangina, percutaneous or surgical revascularization procedure, or intracardiac deviceplacement 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 opinionof the study investigator, might confound the results of the study or pose anadditional risk to the participant by their participation in the study, as definedin the protocol

NOTE: Other protocol-defined inclusion / exclusion criteria apply

Study Design

Total Participants: 9
Treatment Group(s): 1
Primary Treatment: mibavademab
Phase: 3
Study Start date:
December 16, 2024
Estimated Completion Date:
November 03, 2026

Connect with a study center

  • National Institutes of Health

    Bethesda, Maryland 20892
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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