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
Regeneron Pharmaceuticals is advancing mibavademab (REGN4461) as a potential treatment for monogenic obesity linked to LEP gene mutations. This niche indication addresses a specific patient population with unmet medical needs, potentially allowing for premium pricing due to the rarity of the condition. The obesity treatment market is competitive, with several established therapies; however, mibavademab's unique mechanism may differentiate it. The trial's success could position Regeneron favorably in the obesity treatment landscape, particularly as obesity continues to gain attention as a public health issue. Diligence should focus on the trial's enrollment pace and safety profile, as well as potential regulatory hurdles.
Indication: Monogenic Obesity
Modality: small molecule
Target: Leptin receptor agonist targeting biallelic loss of function variants of the LEP gene.
Sponsor: Regeneron Pharmaceuticals
Source URL: ClinicalTrials.gov
Source updated: Detailed source ingestion pending
Ingested: Jul 11, 2026
Model: trialsignal-ai-v1
Validation: validated
Matched by target_normalized: Leptin receptor agonist targeting biallelic loss of function variants of the LEP gene.
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Condition raw: Monogenic Obesity
Condition normalized: Monogenic Obesity
Modality raw: small molecule
Modality normalized: small molecule
Target raw: Leptin receptor agonist targeting biallelic loss of function variants of the LEP gene.
Target normalized: Leptin receptor agonist targeting biallelic loss of function variants of the LEP gene.