DRUG
mibavademab
Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection
Status
Completed
Phase
Phase 3
Enrollment
9
Locations
2
Results
Not posted
Publications
0
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)
Interventions
DRUG
Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection
Timeline
First posted
Aug 12, 2024
Study start
Dec 16, 2024
Primary completion
Jul 9, 2026
Study completion
Jul 9, 2026
Results posted
Not reported
Registry updated
Jul 29, 2026
Outcomes
Incidence of treatment-emergent adverse events (TEAEs)
Time frame · Up to week 68
Severity of TEAEs
Time frame · Up to week 68
Change in Hemoglobin A1c (HbA1c)
Time frame · Baseline, week 20 and week 52
Occurrence of HbA1c <7%
Time frame · Week 20 and week 52
Occurrence of HbA1c <6.5%
Time frame · Week 20 and week 52
Occurrence of requiring therapy with insulin in participants treated with mibavademab
Time frame · Week 20 and week 52
Change in total insulin dose
Time frame · Baseline, week 20 and week 52
Change in fasting plasma glucose
Time frame · Baseline, week 20 and week 52
Percent change in fasting triglycerides
Time frame · Baseline, week 20 and week 52
Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab
Time frame · Baseline, week 20 and week 52
Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab
Time frame · Baseline, week 20 and week 52
Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab
Time frame · Baseline, week 20 and week 52
Eligibility
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
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
National Institutes of Health
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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