NCT07220785

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Generalized Lipodystrophy

Interventions

Type	Name	Description
DRUG	Mibavademab	Administered as per the protocol
DRUG	Placebo	Administered as per the protocol

Timeline

• Start date: 2026-03-13
• Primary completion: 2028-05-19
• Completion: 2028-09-08
• First posted: 2025-10-24
• Last updated: 2026-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study