Tests mibavademab for obesity caused by a leptin gene change
Tests mibavademab in people with obesity caused by a leptin gene change.
Plain-language title generated from the registry record
Registry title: A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Key facts
- Where
- Esplugues de Llobregat, SpainSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children, teenagers and adults with severe obesity caused by a change in the LEP gene that stops it from working. They would take an experimental drug called mibavademab.
- Age
- 2 Years and older
- Sex
- All sexes can join.
- Disease stage
- Class 2 or higher obesity at screening and at baseline, as defined in the protocol.
- Earlier treatment
- Cannot join if treated with weight-loss medicines, or medicines known to cause weight loss, in the past approximately 3 months. Cannot join if currently treated with metreleptin or treated with it before, as defined in the protocol.
- Biomarker or test result
- A documented history of biallelic loss of function variants of the LEP gene before the screening visit.
Main reasons for not taking part
- Bariatric surgery in approximately the past 12 months
- Weight loss of 5% or more of body weight in approximately the past 3 months
- Other genetic causes of obesity besides the LEP gene variants
- Schizophrenia, bipolar disorder or other mental illness that the investigator thinks is a safety risk
- Suicidal ideation of type 4 or 5, or any lifetime history of a suicide attempt or suicidal behavior
Read by machine on 9 November 2026.
Where in Spain
- Hospital Sant Joan De Deu BarcelonaEsplugues de Llobregat, SpainTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Regeneron Pharmaceuticals
- Trial code
- NCT07220772EU 2024-518674-14-00
- Record updated
- 22 October 2026
- Original description
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.Read full original descriptionShow less
An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene
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
Inclusion: Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit; Has class ≥2 obesity at screening and at baseline, as defined in the protocol.
Exclusion: Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening; History of schizophrenia, bipolar disorder, or other mental illness that, in the opinion of the investigator, might pose a safety risk to participation in a clinical study of an investigational drug; Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening; Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol; NOTE: Other Protocol-defined Inclusion/Exclusion Criteria Apply; History of bariatric surgery within approximately the past 12 months of study screening; History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening; History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene; Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) during screening or baseline, or any lifetime history of a suicide attempt, or any lifetime history of suicidal behavior, including ideation.