A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
Recruiting
Phase 3
Interventional Study
Monogenic Obesity
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 4 (estimated)
- Sponsor
- Regeneron Pharmaceuticals · Industry
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About This Trial
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…
Trial Locations
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Eligibility 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 tre…
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