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NCT Number: NCT06548100

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

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)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

  • Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
  • Current chronic treatment with high-dose corticosteroids, as defined in the protocol
  • 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
  • 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
  • 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
  • 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

NOTE: Other protocol-defined inclusion / exclusion criteria apply

Treatment and study plan

Mibavademab

Drug

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

Other names: REGN4461

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to week 68

  2. Severity of TEAEs

    Time frame: Up to week 68

Secondary outcomes

  1. Change in Hemoglobin A1c (HbA1c)

    Time frame: Baseline, week 20 and week 52

  2. Occurrence of HbA1c <7%

    Time frame: Week 20 and week 52

  3. Occurrence of HbA1c <6.5%

    Time frame: Week 20 and week 52

  4. Occurrence of requiring therapy with insulin in participants treated with mibavademab

    Time frame: Week 20 and week 52

  5. Change in total insulin dose

    Time frame: Baseline, week 20 and week 52

  6. Change in fasting plasma glucose

    Time frame: Baseline, week 20 and week 52

  7. Percent change in fasting triglycerides

    Time frame: Baseline, week 20 and week 52

  8. Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab

    Time frame: Baseline, week 20 and week 52

  9. Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab

    Time frame: Baseline, week 20 and week 52

  10. Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab

    Time frame: Baseline, week 20 and week 52

  11. Concentrations of total mibavademab in serum

    Time frame: Up to week 68

  12. Incidence of anti-drug antibodies (ADAs) to mibavademab

    Time frame: Up to week 68

  13. Titer of ADAs to mibavademab

    Time frame: Up to week 68

  14. Incidence of neutralizing antibodies (Nabs) to mibavademab

    Time frame: Up to week 68

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Single-Arm, Open-Label, Safety Study in Patients With Generalized Lipodystrophy Switching From Metreleptin to Mibavademab, A Leptin Receptor Agonist Antibody

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2024
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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