MedTrace Logo

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

NCT07220785 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-05-06

No results posted yet for this 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)

Conditions

  • Generalized Lipodystrophy

Interventions

DRUG

Mibavademab

Administered as per the protocol

DRUG

Placebo

Administered as per the protocol

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-13
Primary Completion
2028-05-19
Completion
2028-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07220785 on ClinicalTrials.gov