A Phase 3 interventional study of mibavademab in Generalized Lipodystrophy, sponsored by Regeneron Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment
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.
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:
941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.
This study's enrollment of 9 is below the median of 62 across 602 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Regeneron Pharmaceuticals is the lead sponsor of 411 studies on the registry; 90 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 79 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined inclusion / exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients switching from at least 6 months of therapy with metreleptin to mibavademab.
Drug: mibavademab
Administered by intravenous (IV) infusion followed by subcutaneous (SC) injection
Also known as: REGN4461
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to week 68
Severity of TEAEs
Time frame: Up to week 68
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline, week 20 and week 52
Occurrence of HbA1c <7%
Time frame: Week 20 and week 52
Occurrence of HbA1c <6.5%
Time frame: Week 20 and week 52
Occurrence of requiring therapy with insulin in participants treated with mibavademab
Time frame: Week 20 and week 52
Change in total insulin dose
Time frame: Baseline, week 20 and week 52
Change in fasting plasma glucose
Time frame: Baseline, week 20 and week 52
Percent change in fasting triglycerides
Time frame: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab
Time frame: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab
Time frame: Baseline, week 20 and week 52
Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab
Time frame: Baseline, week 20 and week 52
Concentrations of total mibavademab in serum
Time frame: Up to week 68
Incidence of anti-drug antibodies (ADAs) to mibavademab
Time frame: Up to week 68
Titer of ADAs to mibavademab
Time frame: Up to week 68
Incidence of neutralizing antibodies (Nabs) to mibavademab
Time frame: Up to week 68
Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: When Regeneron has : received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy
Access criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Ran from Dec 2024 to primary completion in Jul 2026, 18 months.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mibavademab