RECRUITING Phase 3 ClinicalTrials.gov

Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07220785

Registry updated: 2026-09-11

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Description

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 how well mibavademab works and what side effects it has. Researchers will also look at how much mibavademab is in the body at different times. This is a 2-part study: Part A is an efficacy study in pediatric and adult participants, Part B is a safety and pharmacokinetic study in pediatric participants. The study is researching several other questions, including: * How mibavademab affects the amount of sugar in the blood * How mibavademab affects the amount of fat (triglycerides) in the blood * How mibavademab affects the amount of fat that has built up in the liver * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)

Interventions

Mibavademab (Drug)
Administered as per the protocol
Placebo (Drug)
Administered as per the protocol

Eligibility criteria

Key Inclusion Criteria: 1\. Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines For Part A only: 1. Participants ≥2 years of age at screening 2. 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) 3. Weight ≥15 kg at screening 4. 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: 1. Participants \<12 years of age at screening 2. Weighing ≥7 kg at screening 3. No metabolic criteria for study entry is required, as described in the protocol Key Exclusion Criteria: 1. Has a current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus 2. Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol 3. 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 4. History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the protocol 5. 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: 1. Treatment with metreleptin within 3 months of the screening visit 2. 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 3. Significant changes to lifestyle and diet, as described in the protocol 4. 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.

Conditions

Generalized Lipodystrophy

Locations

University of Michigan — Ann Arbor, Michigan, United States
UT Southwestern Medical Center — Dallas, Texas, United States
Walter Cantidio University Hospital, Federal University of Ceara - Ebserh — Fortaleza, Ceará, Brazil
Centro de Pesquisas Clinicas de Natal (Cepclin) — Natal, Rio Grande do Norte, Brazil
Hospital Das Clinicas - School of Medicine Ribeirao Preto, University of Sao Paulo — Ribeirão Preto, São Paulo, Brazil
Hopital Universitaire Robert-Debre — Paris, France
Assistance Publique-Hopitaux de Paris (AP-HP) — Paris, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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