Generalized LipodystrophyPhase 3NCT06548100

A Study of the Safety of Mibavademab in Pediatric and Adult Participants Switching From Metreleptin to Mibavademab for the Treatment of Generalized Lipodystrophy (GLD)

A Phase 3 study testing mibavademab in people with Generalized Lipodystrophy, run by Regeneron Pharmaceuticals at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 2 years and older
Conditions the study is for: Generalized Lipodystrophy
What is being tested?: mibavademab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 2 sitesUnited States
Study dates: 16 Dec 2024to 9 Jul 2026
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines
Treatment with metreleptin for ≥6 months at time of screening at a stable dose, defined as no change in dose within the last 3 months prior to screening
Generally stable diet (based on participant's recall) and stable medication regimen for diabetes and/or dyslipidemia (in addition to metreleptin), for the last 3 months prior to screening
Willing and able to comply with clinic visits and study-related procedures. Participants who are unable/unwilling to self-inject, but are willing to have a capable caregiver inject, are considered eligible
Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting triglycerides from at least 6 months prior to screening, as defined in the protocol

Who cannot join

Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
Current chronic treatment with high-dose corticosteroids, as defined in the protocol
Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit except for fully treated basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus
Estimated glomerular filtration rate (GFR) of <30 mL/min/1.73 m^2 based on chronic kidney disease epidemiology collaboration (CKD-EPI)/Schwartz equation at screening. Assessment can be repeated once
History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure, or intracardiac device placement within 3 months before the screening visit, as defined in the protocol
Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study, as defined in the protocol
NOTE: Other protocol-defined inclusion / exclusion criteria apply

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan
Ann Arbor, Michigan, 48109
National Institutes of Health
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Single-Arm, Open-Label, Safety Study in Patients With Generalized Lipodystrophy Switching From Metreleptin to Mibavademab, A Leptin Receptor Agonist Antibody

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:

What side effects may happen from taking mibavademab
How much mibavademab is in the blood at different times
Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)

Conditions: Generalized Lipodystrophy
Being tested: mibavademab
Keywords: Congenital or acquired generalized lipodystrophy, Leptin deficiency, Loss of subcutaneous tissue, Nutritional deprivation, Severe metabolic derangements, Severe diabetes mellitus, Hypertriglyceridemia, Berardinelli-Seip Syndrome, Lawrence Syndrome, Severe Insulin Resistance
Medical subject headings: Lipodystrophy, Congenital Generalized, Obesity, Morbid, Diabetes Mellitus, Hypertriglyceridemia, Lipodystrophy, Familial Partial, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

mibavademabDrug
Also called REGN4461
Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection

Study groups in NCT06548100
Study group	Role	What they receive
mibavademab	Experimental	Patients switching from at least 6 months of therapy with metreleptin to mibavademab. Receives: Drug: mibavademab

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to week 68
Severity of TEAEs
Measured: Up to week 68

Secondary outcomes (14)

Change in Hemoglobin A1c (HbA1c)
Measured: Baseline, week 20 and week 52
Occurrence of HbA1c <7%
Measured: Week 20 and week 52
Occurrence of HbA1c <6.5%
Measured: Week 20 and week 52
Occurrence of requiring therapy with insulin in participants treated with mibavademab
Measured: Week 20 and week 52
Change in total insulin dose
Measured: Baseline, week 20 and week 52
Change in fasting plasma glucose
Measured: Baseline, week 20 and week 52
Percent change in fasting triglycerides
Measured: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab
Measured: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab
Measured: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab
Measured: Baseline, week 20 and week 52
Concentrations of total mibavademab in serum
Measured: Up to week 68
Incidence of anti-drug antibodies (ADAs) to mibavademab
Measured: Up to week 68
Titer of ADAs to mibavademab
Measured: Up to week 68
Incidence of neutralizing antibodies (Nabs) to mibavademab
Measured: Up to week 68

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 20249 Jul 2026

First posted12 Aug 2024
Study start16 Dec 2024
Primary completion9 Jul 2026
Study completion9 Jul 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Generalized LipodystrophyStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06548100
Sponsor's protocol ID: R4461-GLD-2284
Other IDs: 2024-513202-54-00, 2026-000121-16
Status last verified: Jul 2026
First submitted: 7 Aug 2024
Last updated: 29 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Expanded access: Available

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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