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Generalized LipodystrophyPhase 3LAGONCT07220785

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

A Phase 3 study testing Mibavademab in people with Generalized Lipodystrophy, run by Regeneron Pharmaceuticals at 9 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
9 sitesin 3 countries
Study dates
13 Mar 2026to 8 Sep 2028
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

  • 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
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  • 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)
  • 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

Who cannot join

  • 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:
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  • 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 medications, as described in the protocol
  • 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.

Trial locations and contacts

9 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Administrator contact

844-734-6643

clinicaltrials@regeneron.com

9 sites in 3 countries

Brazil5 sites, 5 recruiting

  • Walter Cantidio University Hospital, Federal University of Ceara - Ebserh

    Fortaleza, Ceará, 60430-270

    Recruiting

  • Centro de Pesquisas Clinicas de Natal (Cepclin)

    Natal, Rio Grande do Norte, 59025-050

    Recruiting

  • UPCO - HCPA - Universidade Federal do Rio Grande do Sul - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

    Recruiting

  • Hospital Das Clinicas - School of Medicine Ribeirao Preto, University of Sao Paulo

    Ribeirão Preto, São Paulo, 14040-906

    Recruiting

  • Instituto Estadual de Diabetes e Endcrinologia

    Rio de Janeiro, 20211-340

    Recruiting

Other trials in Brazil

United States2 sites, 2 recruiting

  • University of Michigan

    Ann Arbor, Michigan, 48109

    Recruiting

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

    Recruiting

Other trials in United States

France2 sites, 2 recruiting

  • Hopital Universitaire Robert-Debre

    Paris, 75019

    Recruiting

  • Assistance Publique-Hopitaux de Paris (AP-HP)

    Paris, 75571

    Recruiting

Other trials in France

About this study

Official title: A Two-Part, Randomized, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Mibavademab in Patients With Generalized Lipodystrophy (LAGO)

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.

Read more

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)
Being tested
Mibavademab, Placebo
Keywords
Subcutaneous (SC) adipose tissue, GLD, Berardinelli-Seip Syndrome, Congenital Generalized Lipodystrophy, CGL, Lawrence Syndrome, Acquired Generalized Lipodystrophy, AGL
Medical subject headings
Lipodystrophy, Congenital Generalized, Lipodystrophy, Familial Partial

What participants receive

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

  • MibavademabDrug

    Also called REGN4461

    Administered as per the protocol

  • PlaceboDrug

    Administered as per the protocol

Study groups in NCT07220785
Study groupRoleWhat they receive
Part A: Arm AExperimentalNot described
Receives: Drug: Mibavademab
Part A: Arm BExperimentalNot described
Receives: Drug: Mibavademab; Drug: Placebo
Part A: Arm CExperimentalNot described
Receives: Drug: Mibavademab
Part A: Arm DPlacebo comparatorNot described
Receives: Drug: Placebo
Part BExperimentalNot described
Receives: Drug: Mibavademab

What is being measured

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

  1. Change in Hemoglobin A1c (HbA1c)

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  2. Percent change in fasting Triglycerides (TG)

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  3. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Part B

    Measured: Up to 15 months

  4. Severity of TEAEs

    Part B

    Measured: Up to 15 months

  5. Concentrations of total mibavademab in serum

    Part B

    Measured: Up to 15 months

Secondary outcomes (34)

  1. Change in HbA1c compared to placebo

    Part A

    Measured: From baseline to week 20

  2. Change in HbA1c compared to placebo

    Part A

    Measured: From week 56 to week 64

  3. Change in HbA1c

    Part B

    Measured: From baseline to week 52

  4. Percent change in fasting TG compared to placebo

    Part A

    Measured: From baseline to week 20

  5. Percent change in fasting TG compared to placebo

    Part A

    Measured: From week 56 to week 64

  6. Percent change in fasting TG

    Part B

    Measured: From baseline to week 52

  7. Occurrence of HbA1c <7%

    Part A

    Measured: At week 20

  8. Occurrence of HbA1c <7%

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  9. Occurrence of HbA1c <6.5%

    Part A

    Measured: At week 20

  10. Occurrence of HbA1c <6.5%

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  11. Occurrence of fasting TG <500 mg/dL

    Part A

    Measured: At week 20

  12. Occurrence of fasting TG <500 mg/dL

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  13. Occurrence of fasting TG <200 mg/dL

    Part A

    Measured: At week 20

  14. Occurrence of fasting TG <200 mg/dL

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  15. Occurrence of fasting TG <150 mg/dL

    Part A

    Measured: At week 20

  16. Occurrence of fasting TG <150 mg/dL

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  17. Percent change in Liver Fat Content (LFC)

    Part A

    Measured: From baseline to week 20

  18. Percent change in Liver Fat Content (LFC)

    Part A

    Measured: From pre-mibavademab exposure to week 56

  19. Change in liver volume

    Part A

    Measured: From baseline to week 20

  20. Change in liver volume

    Part A

    Measured: From pre-mibavademab exposure to week 56

  21. Change in fasting glucose

    Part A

    Measured: From baseline to week 20

  22. Change in fasting glucose

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  23. Change in fasting glucose

    Part A

    Measured: From week 56 to week 64

  24. Change in total daily insulin dose

    Part A

    Measured: From baseline to week 20

  25. Change in total daily insulin dose

    Part A

    Measured: Through 36 weeks of exposure to mibavademab

  26. Change in total daily insulin dose

    Part A

    Measured: From week 56 to week 64

  27. Change in total daily insulin dose

    Part B

    Measured: From baseline to week 52

  28. Concentrations of total mibavademab in serum

    Part A

    Measured: Through Week 72

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

    Part A

    Measured: Through Week 72

  30. Occurrence of ADA to mibavademab

    Part B

    Measured: Through Week 60

  31. Magnitude of ADA to mibavademab

    Part A

    Measured: Through Week 72

  32. Magnitude of ADA to mibavademab

    Part B

    Measured: Through Week 60

  33. Occurrence of TEAEs

    Part A

    Measured: Through Week 72

  34. Severity of TEAEs

    Part A

    Measured: Through Week 72

Timeline

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

  1. First posted24 Oct 2025
  2. Study start13 Mar 2026
  3. Primary completion19 May 2028 (estimated)
  4. Study completion8 Sep 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Part A will be double blinded; Part B will be open label
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07220785
Sponsor's protocol ID
R4461-GLD-2285
Other IDs
2024-519879-25-00
Acronym
LAGO
Status last verified
Oct 2026
First submitted
22 Oct 2025
Last updated
23 Oct 2026
Results posted
No
Data monitoring committee
Yes
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

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