Status:
NOT_YET_RECRUITING
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Generalized Lipodystrophy
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
This study is researching a new drug called mibavademab (called "study drug"). The study involves participants with a condition called Generalized Lipodystrophy (GLD). The aim of the study is to see h...
Eligibility Criteria
Inclusion
- Key
- 1\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines
- For Part A only:
- Participants ≥2 years of age at screening
- At least one of the below criteria are fulfilled during screening (measurements can be repeated once during screening period)
- HbA1c ≥7%
- Fasting TG ≥500 mg/dL
- Fasting TG value of ≥300 mg/dL and the presence of another complication of GLD consistent with leptin deficiency (history of diabetes mellitus, hyperphagia, Metabolic Associated Fatty Liver Disease (MAFLD), polycystic ovary syndrome, etc)
- Weight ≥15 kg at screening
- Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting TG from at least 6 months prior to screening, as described in the protocol
- For Part B only:
- Participants ≥2 and \<12 years of age at screening
- No metabolic criteria or minimum weight for study entry is required
- Key
Exclusion
- Has a current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus
- Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol
- eGFR of \<30 mL/min/1.73 m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine or Schwartz equation, as applicable, at screening. Assessment can be repeated once
- History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the protocol
- Treatment with over-the-counter or prescription medications with the intention of weight loss within 3 months prior to the screening visit
- For Part A only:
- Treatment with metreleptin within 3 months of the screening visit
- Addition or discontinuation of prescription medications or over-the-counter supplements for diabetes and/or dyslipidemia within 3 months prior to the start of the screening period, or changes in the use of these medications, as described in the protocol
- Significant changes to lifestyle and diet, as described in the protocol
- Current chronic treatment with high-dose corticosteroids, defined as use of higher than physiologic doses, as described in the protocol
- NOTE: Other protocol defined inclusion/exclusion criteria apply.
Key Trial Info
Start Date :
January 30 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 8 2028
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT07220785
Start Date
January 30 2026
End Date
September 8 2028
Last Update
October 24 2025
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