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

Launched by REGENERON PHARMACEUTICALS · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new experimental drug called mibavademab for people with a condition known as Generalized Lipodystrophy (GLD). The trial is specifically for individuals who have been receiving treatment with a medication called metreleptin for at least six months and have not changed their dose in the last three months. The main goal is to find out how safe and tolerable mibavademab is when switching from metreleptin. Researchers will also look at potential side effects, how the drug behaves in the body, and whether the body develops antibodies against it, which could affect its effectiveness.

To be eligible for this study, participants need to have a confirmed diagnosis of GLD and have been stable on metreleptin treatment. They should also have a consistent diet and medication routine for diabetes or fat-related issues for three months before the screening. Participants will need to attend clinic visits and may have a caregiver help with injections if needed. It's important to note that certain health issues, like recent heart problems or specific cancers, might prevent someone from joining the study. Overall, participants can expect close monitoring during the trial to ensure their safety while exploring a new treatment option for GLD.

Gender

ALL

Eligibility criteria

• Key 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
• Key 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
• • NOTE: Other protocol-defined inclusion / exclusion criteria apply