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

Study acronym: LAGO
StatusRecruiting
PhasePhase 3
Started2026-03-13
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v8
Study sites5→7
2026-08-17
Study Status, Contacts/Locations v7
Study sites4→5
2026-08-04
Study Status, Contacts/Locations v6
Study sites3→4
2026-07-10
Study Status, Contacts/Locations v5
Study sites2→3
2026-05-05
Study Status, Contacts/Locations v4
Study sites1→2
Show 3 earlier versions
2026-04-07
Study Identification, Study Status, Oversight, Outcome Measures, Eligibility v3
Eligibility criteria+33 characters
[...] , as described in the protocol For Part B only: Participants ≥2 and <12 years of age at screening Weighing ≥7 kg at screening No metabolic criteria or minimum weight for study entry is required, as described in the protocol Key Exclusion Criteria: Has a current diagnosis of familial [...]
Secondary endpoints34 entries, revised
Occurrence of antiAnti-drugDrug antibodiesAntibodies (ADA) to mibavademab TiterMagnitude of ADA to mibavademab TiterMagnitude of ADA to mibavademab
2026-03-23
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2026-02-27→confirmed 2026-03-13
Study sites0→1
2026-02-03
Study Status v1
Start date2026-01-30→2026-02-27
2025-10-22
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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)
Trial Details
NCT Number NCT07220785
Lead Sponsor Regeneron Pharmaceuticals
Conditions Generalized Lipodystrophy
Enrollment 28 participants
Start Date 2026-03-13
Primary Completion 2028-05-19 (estimated)
Study Completion 2028-09-08 (estimated)
Updated on ClinicalTrials.gov 2026-09-11