Mibavademab for obesity caused by leptin (LEP) gene mutations in children, adolescents, and adults
Official title: 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
Run by Regeneron Pharmaceuticals · NCT07220772 · Data updated 2026-11-12
This trial will try mibavademab in children, adolescents, and adults with leptin gene–related obesity to help control body weight and check safety.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years and up |
| Sex | All |
| Enrollment | 4 (estimated) |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | mibavademab |
| Locations | 3 sites (Ulm and 2 other locations) |
| Status | Recruiting |
| Started | February 9, 2026 |
| Main results expected | June 18, 2027 |
| Study ends | April 21, 2028 |
| Registry record updated | October 22, 2026 |
| Trial ID | NCT07220772 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children, adolescents, or adults with confirmed biallelic loss-of-function LEP mutations, class ≥2 obesity, and available historical weight documentation.
✕Probably not a fit
People with other genetic causes of obesity, recent bariatric surgery, recent weight loss of ≥5%, or certain disqualifying psychiatric conditions are unlikely to benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial gives mibavademab to people with biallelic loss-of-function variants in the LEP gene and class ≥2 obesity. Participants will receive mibavademab and be followed for changes in body weight, safety and side effects, blood drug levels, and whether the body develops antibodies to the drug. The protocol requires documented historical weight records and excludes recent bariatric surgery, recent significant weight loss, other genetic causes of obesity, and certain psychiatric conditions. The study is sponsored by Regeneron and conducted at Ulm University Medical Centre.
Why it matters
Potential benefit: If successful, mibavademab could substantially reduce hunger and produce meaningful weight loss for people whose obesity is caused by leptin deficiency.
How similar studies have gone: Leptin-replacement approaches have previously improved hunger and weight in people with congenital leptin deficiency, though mibavademab itself is a newer therapy now in late-stage testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
ULM University Medical Centre
Ulm, Germany Recruiting -
Ankara Education and Research Hospital
Ankara, Turkey (Türkiye) Recruiting -
Erciyes University
Kayseri, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Mibavademab for adult women with functional hypothalamic amenorrhea
This trial tests whether the experimental drug mibavademab helps adult women with functional hypothalamic amenorrhea make the hormones needed to resume ovulation and menstrual cycles.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.