Status:
NOT_YET_RECRUITING
A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Monogenic Obesity
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief Summary
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 gen...
Eligibility Criteria
Inclusion
- Key
- 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
- Key
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 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
- 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
- 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
- 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
Key Trial Info
Start Date :
December 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2028
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT07220772
Start Date
December 19 2025
End Date
March 30 2028
Last Update
October 24 2025
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