Actively Recruiting
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Led by Regeneron Pharmaceuticals · Updated on 2026-05-06
28
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of congenital or acquired generalized lipodystrophy (GLD) according to Multi-Society Practice Guidelines
- For Part A: Participants 2 years of age or older at screening
- For Part A: At least one of the following during screening (repeat allowed): HbA1c ≥7%, fasting triglycerides ≥500 mg/dL, or fasting triglycerides ≥300 mg/dL with another GLD complication such as diabetes, hyperphagia, fatty liver, or polycystic ovary syndrome
- For Part A: Weight of at least 15 kg at screening
- For Part A: Willing and able to provide or have physician provide HbA1c and fasting triglyceride values from at least 6 months prior to screening
- For Part B: Participants younger than 12 years at screening
- For Part B: Weight of at least 7 kg at screening
- For Part B: No metabolic criteria required for study entry
You will not qualify if you...
- Current diagnosis of familial or acquired partial lipodystrophy or autoimmune (Type 1) diabetes mellitus
- Any malignancy, such as lymphoma, within 1 year prior to screening
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 at screening; assessment may be repeated once
- History of hospitalization for heart failure, myocardial infarction, stroke, or significant arrhythmia
- Use of medications intended for weight loss within 3 months prior to screening
- For Part A: Treatment with metreleptin within 3 months prior to screening
- For Part A: Changes in diabetes or dyslipidemia medications or supplements within 3 months prior to screening
- For Part A: Significant lifestyle or diet changes prior to screening
- For Part A: Current chronic treatment with high-dose corticosteroids above physiological doses
- Other protocol-defined inclusion/exclusion criteria may also apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
2
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here