RecruitingPhase 3NCT07220785

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)


Sponsor

Regeneron Pharmaceuticals

Enrollment

28 participants

Start Date

Mar 13, 2026

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 2 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Mibavademab and a drug called Placebo for people with generalized lipodystrophy. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGMibavademab

Administered as per the protocol

DRUGPlacebo

Administered as per the protocol


Locations(3)

University of Michigan

Ann Arbor, Michigan, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Assistance Publique-Hopitaux de Paris (AP-HP)

Paris, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07220785


Related Trials