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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513202-54-00 | EU Trial (CTIS) Number | ||
| 2026-000121-16 | EudraCT Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mibavademab | Experimental | Patients switching from at least 6 months of therapy with metreleptin to mibavademab. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mibavademab | Drug | Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | Up to week 68 | |
| Severity of TEAEs | Up to week 68 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin A1c (HbA1c) | Baseline, week 20 and week 52 | |
| Occurrence of HbA1c <7% | Week 20 and week 52 | |
| Occurrence of HbA1c <6.5% |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion / exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health | Bethesda | Maryland | 20892 | United States | ||
| University of Michigan |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
When Regeneron has :
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| Week 20 and week 52 |
| Occurrence of requiring therapy with insulin in participants treated with mibavademab | Week 20 and week 52 |
| Change in total insulin dose | Baseline, week 20 and week 52 |
| Change in fasting plasma glucose | Baseline, week 20 and week 52 |
| Percent change in fasting triglycerides | Baseline, week 20 and week 52 |
| Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab | Baseline, week 20 and week 52 |
| Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab | Baseline, week 20 and week 52 |
| Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab | Baseline, week 20 and week 52 |
| Concentrations of total mibavademab in serum | Up to week 68 |
| Incidence of anti-drug antibodies (ADAs) to mibavademab | Up to week 68 |
| Titer of ADAs to mibavademab | Up to week 68 |
| Incidence of neutralizing antibodies (Nabs) to mibavademab | Up to week 68 |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| ID | Term |
|---|---|
| D052497 | Lipodystrophy, Congenital Generalized |
| D009767 | Obesity, Morbid |
| D003920 | Diabetes Mellitus |
| D015228 | Hypertriglyceridemia |
| D052496 | Lipodystrophy, Familial Partial |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D008052 | Lipid Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008060 | Lipodystrophy |
| D012875 | Skin Diseases, Metabolic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D000083083 | Laminopathies |
| D006946 | Hyperinsulinism |
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