Actively Recruiting
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Led by Regeneron Pharmaceuticals · Updated on 2026-03-10
4
Participants Needed
1
Research Sites
114 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called monogenic obesity. Monogenic obesity is caused by a change in the leptin gene that keeps it from working properly. This causes the body to not be able to feel full or control feelings of hunger. The aim of the study is to see how well mibavademab controls the body weight and how safe it is. The study is looking at several other research questions, including: * How much mibavademab is in the blood at different times * Whether the body makes proteins called antibodies against mibavademab (which could stop mibavademab from working as well or could lead to side effects) * What side effects may happen from taking mibavademab
CONDITIONS
Official Title
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented medical history of biallelic loss of function variants of the LEP gene before screening
- Presence of class 2 or higher obesity at screening and baseline as defined in the protocol
You will not qualify if you...
- Unable or unwilling to provide documented weight history for at least 6 months before screening
- History of bariatric surgery within 12 months before screening
- Weight loss of 5% or more in the 3 months before screening
- Having genetic causes of obesity other than or in addition to biallelic loss of function variants of the LEP gene
- History of schizophrenia, bipolar disorder, or other mental illness posing safety risks as judged by the investigator
- Any suicidal ideation type 4 or 5 during screening or lifetime history of suicide attempt or suicidal behavior
- Treatment with weight loss medications or medications causing weight loss in the 3 months before screening
- Current or past treatment with metreleptin as defined in the protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
ULM University Medical Centre
Ulm, Germany, 89075
Actively Recruiting
Research Team
C
Clinical Trials Administrator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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