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Tests treatment safety and results for Generalized Lipodystrophy
Official title Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
ClinicalTrials.gov ID: NCT07220785
What this study is testing
What is Mibavademab?
Mibavademab is an investigational medicine, being studied as a potential treatment for generalized lipodystrophy.
Also referred to as REGN4461.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is researching a new drug called mibavademab (called "study drug"). The study involves participants with a condition called Generalized Lipodystrophy (GLD).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
You may be able to join if
- 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
You likely can't join if
- 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...
- History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, as described in the...
- 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...
- Treatment with metreleptin within 3 months of the screening visit
See the full eligibility criteria
- 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...
- 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 \<12 years of age at screening
- Weighing ≥7 kg at screening
- No metabolic criteria for study entry is required, as described in the protocol Key
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
- Dallas, Texas, United States
- Paris, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States; Dallas, Texas, United States; Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.