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RecruitingNCT07220785LAGOUpdated Oct 23, 2026

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

A Phase 3 interventional study of Mibavademab and Placebo in Generalized Lipodystrophy, sponsored by Regeneron Pharmaceuticals. Recruiting at 9 sites in 3 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2026; still recruiting 7 months later.
Updated Oct 23, 20262 sites addedGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

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)
02

Conditions studied

  • Generalized Lipodystrophy

Keywords

  • Subcutaneous (SC) adipose tissue
  • GLD
  • Berardinelli-Seip Syndrome
  • Congenital Generalized Lipodystrophy
  • CGL
  • Lawrence Syndrome
  • Acquired Generalized Lipodystrophy
  • AGL
03

In context

Lipodystrophy, Familial Partial

20 studies on the registry are indexed under Lipodystrophy, Familial Partial; 5 are open to participants now.

This study's planned enrollment of 28 is above the median of 16 across 14 interventional studies indexed under Lipodystrophy, Familial Partial.

Browse Lipodystrophy, Familial Partial studies →

Lead sponsor

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.

Browse Regeneron Pharmaceuticals studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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)

    • ≥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 (Type 1) diabetes mellitus
  2. Any , eg, lymphoma, within the past 1 year, prior to screening visit, as described in the protocol
  3. 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, 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 , defined as use of higher than physiologic doses, as described in the protocol

NOTE: Other protocol defined inclusion/exclusion criteria apply.

Terms in these criteria, in plain language(6)

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.

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.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

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.

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.

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.

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Experimental
    Part A: Arm A

    Drug: Mibavademab

  • Experimental
    Part A: Arm B

    Drug: Mibavademab · Drug: Placebo

  • Experimental
    Part A: Arm C

    Drug: Mibavademab

  • Placebo comparator
    Part A: Arm D

    Drug: Placebo

  • Experimental
    Part B

    Drug: Mibavademab

Interventions

  • DrugMibavademab

    Administered as per the protocol

    Also known as: REGN4461

  • DrugPlacebo

    Administered as per the protocol

06

What researchers measure

Primary outcomes

  1. Change in Hemoglobin A1c (HbA1c)

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  2. Percent change in fasting Triglycerides (TG)

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  3. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Part B

    Time frame: Up to 15 months

  4. Severity of TEAEs

    Part B

    Time frame: Up to 15 months

  5. Concentrations of total mibavademab in serum

    Part B

    Time frame: Up to 15 months

Secondary outcomes

  1. Change in HbA1c compared to placebo

    Part A

    Time frame: From baseline to week 20

  2. Change in HbA1c compared to placebo

    Part A

    Time frame: From week 56 to week 64

  3. Change in HbA1c

    Part B

    Time frame: From baseline to week 52

  4. Percent change in fasting TG compared to placebo

    Part A

    Time frame: From baseline to week 20

  5. Percent change in fasting TG compared to placebo

    Part A

    Time frame: From week 56 to week 64

  6. Percent change in fasting TG

    Part B

    Time frame: From baseline to week 52

  7. Occurrence of HbA1c <7%

    Part A

    Time frame: At week 20

  8. Occurrence of HbA1c <7%

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  9. Occurrence of HbA1c <6.5%

    Part A

    Time frame: At week 20

  10. Occurrence of HbA1c <6.5%

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  11. Occurrence of fasting TG <500 mg/dL

    Part A

    Time frame: At week 20

  12. Occurrence of fasting TG <500 mg/dL

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  13. Occurrence of fasting TG <200 mg/dL

    Part A

    Time frame: At week 20

  14. Occurrence of fasting TG <200 mg/dL

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  15. Occurrence of fasting TG <150 mg/dL

    Part A

    Time frame: At week 20

  16. Occurrence of fasting TG <150 mg/dL

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  17. Percent change in Liver Fat Content (LFC)

    Part A

    Time frame: From baseline to week 20

  18. Percent change in Liver Fat Content (LFC)

    Part A

    Time frame: From pre-mibavademab exposure to week 56

  19. Change in liver volume

    Part A

    Time frame: From baseline to week 20

  20. Change in liver volume

    Part A

    Time frame: From pre-mibavademab exposure to week 56

  21. Change in fasting glucose

    Part A

    Time frame: From baseline to week 20

  22. Change in fasting glucose

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  23. Change in fasting glucose

    Part A

    Time frame: From week 56 to week 64

  24. Change in total daily insulin dose

    Part A

    Time frame: From baseline to week 20

  25. Change in total daily insulin dose

    Part A

    Time frame: Through 36 weeks of exposure to mibavademab

  26. Change in total daily insulin dose

    Part A

    Time frame: From week 56 to week 64

  27. Change in total daily insulin dose

    Part B

    Time frame: From baseline to week 52

  28. Concentrations of total mibavademab in serum

    Part A

    Time frame: Through Week 72

  29. Occurrence of Anti-Drug Antibodies (ADA) to mibavademab

    Part A

    Time frame: Through Week 72

  30. Occurrence of ADA to mibavademab

    Part B

    Time frame: Through Week 60

  31. Magnitude of ADA to mibavademab

    Part A

    Time frame: Through Week 72

  32. Magnitude of ADA to mibavademab

    Part B

    Time frame: Through Week 60

  33. Occurrence of TEAEs

    Part A

    Time frame: Through Week 72

  34. Severity of TEAEs

    Part A

    Time frame: Through Week 72

07

Study locations

9 of 9 sites recruiting
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
    Recruiting
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
    Recruiting
  • Walter Cantidio University Hospital, Federal University of Ceara - Ebserh
    Fortaleza, Ceará 60430-270, Brazil
    Recruiting
  • Centro de Pesquisas Clinicas de Natal (Cepclin)
    Natal, Rio Grande do Norte 59025-050, Brazil
    Recruiting
  • UPCO - HCPA - Universidade Federal do Rio Grande do Sul - UFRGS
    Porto Alegre, Rio Grande do Sul 90035-903, Brazil
    Recruiting
  • Hospital Das Clinicas - School of Medicine Ribeirao Preto, University of Sao Paulo
    Ribeirão Preto, São Paulo 14040-906, Brazil
    Recruiting
  • Instituto Estadual de Diabetes e Endcrinologia
    Rio de Janeiro, 20211-340, Brazil
    Recruiting
  • Hopital Universitaire Robert-Debre
    Paris, 75019, France
    Recruiting
  • Assistance Publique-Hopitaux de Paris (AP-HP)
    Paris, 75571, France
    Recruiting
08

References and documents

Individual participant data

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 the study 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.

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites added
Show 2 added (2 Brazil)
  • UPCO - HCPA - Universidade Federal do Rio Grande do Sul - UFRGS · Porto Alegre, Brazil
  • Instituto Estadual de Diabetes e Endcrinologia · Rio de Janeiro, Brazil
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    2 sites added
    Show 2 added (2 Brazil)
    • UPCO - HCPA - Universidade Federal do Rio Grande do Sul - UFRGS · Porto Alegre, Brazil
    • Instituto Estadual de Diabetes e Endcrinologia · Rio de Janeiro, Brazil
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07220785
Lead sponsor
Regeneron Pharmaceuticals
Responsible party
Sponsor
First posted
Oct 24, 2025
Start date
Mar 13, 2026
Primary completion
May 19, 2028 (estimated)
Completion
Sep 8, 2028 (estimated)
Last update
Oct 23, 2026

Study contacts

Clinical Trials Administrator
Contact
clinicaltrials@regeneron.com
844-734-6643
Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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