NCT07220772RecruitingPhase 3
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
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
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 4 (estimated)
- First submitted
- 22 Oct 2025
- Start date
- 9 Feb 2026
- Primary completion date
- 18 Jun 2027
- Lead sponsor
- Regeneron Pharmaceuticals
- Diseases
- Obesity
- NCT number
- NCT07220772
- EU CT number
- 2024-518674-14-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 4
- From 9 Feb 2026 to the primary completion date, 18 Jun 2027
- 4 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitaetsklinikum Ulm AoR Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| Hospital Sant Joan De Deu Barcelona Coordinator of this site? Confirm its status | Esplugues de Llobregat | Spain | Recruiting |
| Ankara Education and Research Hospital Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Recruiting |
| Erciyes University Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.