A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults

Plain-language summary

This study evaluates the drug Mibavademab for treating obesity caused by mutations in the leptin (LEP) gene in children, adolescents and adults. People with documented biallelic loss-of-function variants of the LEP gene and class 2 or higher obesity may take part. The study is in Phase 3 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 3

Status

Recruiting

Sponsor

Regeneron Pharmaceuticals

Intervention

Mibavademab

Start date

2/9/2026

Estimated completion

4/21/2028

Countries

Germany

Related genes

Locations

• Ulm, Germany

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Key Inclusion Criteria:

1. Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit
2. Has class ≥2 obesity at screening and at baseline, as defined in the protocol

Key Exclusion Criteria:

1. Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening
2. History of bariatric surgery within approximately the past 12 months of study screening
3. History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening
4. History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene
5. 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
6. 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
7. Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening
8. 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