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28 Participants NeededMy employer runs this trial

Mibavademab for Generalized Lipodystrophy

(LAGO Trial)

Recruiting at 1 trial location
CT
Overseen ByClinical Trials Administrator
Age: Any Age
Sex: Any
Trial Phase: Phase 3
Sponsor: Regeneron Pharmaceuticals
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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)

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with GLD by my doctor.
I am at least 2 years old, weigh at least 15 kg, and meet one of the required lab criteria.
I am under 12 years old and weigh at least 7 kg.

Exclusion Criteria

I have partial lipodystrophy or Type 1 diabetes.
My kidney function is severely reduced (eGFR less than 30).
I have had heart failure, a heart attack, stroke, or serious heart rhythm problems.
See 3 more

What Are the Treatments Tested in This Trial?

Interventions

  • Mibavademab

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part BExperimental Treatment1 Intervention
Group II: Part A: Arm CExperimental Treatment1 Intervention
Group III: Part A: Arm BExperimental Treatment2 Interventions
Group IV: Part A: Arm AExperimental Treatment1 Intervention
Group V: Part A: Arm DPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

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