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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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Germany
ULM University Medical Centre
RECRUITING
Ulm
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2026-02-09
Estimated Completion Date: 2028-04-21
Participants
Target number of participants: 4
Treatments
Experimental: Mibavademab
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov