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

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Study sites: 2 to 3
  2. Study sites: 1 to 2
    • Eligibility criteria expanded, about 10 words
    • Secondary endpoints: details revised at 3 of 17 entries
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 1
    • Primary completion date: Apr 9, 2027 to Jun 18, 2027
    • Study completion date: Mar 30, 2028 to Apr 21, 2028
    • Start date changed from estimate of Dec 19, 2025 to Feb 9, 2026
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Regeneron
154 trials monitored
See 14 trials at risk
Obesity
3,903 trials monitored
See 160 trials at risk
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
Trial Details
NCT Number NCT07220772
Lead Sponsor Regeneron Pharmaceuticals
Conditions
(from sponsor)		 Monogenic Obesity
Related terms Obesity, Morbid
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov