Phase
Condition
Skin Lipomas
Treatment
mibavademab
Clinical Study ID
Ages > 2 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Diagnosis of congenital or acquired GLD as defined by Multi-Society PracticeGuidelines
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 regimenfor diabetes and/or dyslipidemia (in addition to metreleptin), for the last 3 monthsprior 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 acapable caregiver inject, are considered eligible
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:
Treatment with over-the-counter or prescription medications for weight loss within 3months 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 visitexcept for fully treated basal cell or squamous epithelial cell carcinomas of theskin or carcinoma in situ of the cervix or anus
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
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
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
Connect with a study center
National Institutes of Health
Bethesda, Maryland 20892
United StatesSite Not Available
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
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