A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
NCT07220772 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2026-03-10
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
Conditions
- Monogenic Obesity
Interventions
- DRUG
-
Mibavademab
Administered as per the protocol
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-09
- Primary Completion
- 2027-06-18
- Completion
- 2028-04-21
- FDA Drug
- Yes
Countries
- Germany
Study Locations
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