This study is looking at monogenic obesity, which is a specific type of severe weight problem caused by changes in a single gene. In this case, the study focuses on people who have mutations in both copies of the LEP gene, which normally helps control body weight and appetite. People with these gene changes often experience extreme hunger and severe obesity from an early age. The treatment being tested is mibavademab, also known by its code name REGN4461, which is given as an injection solution either into a vein, under the skin, or into a muscle. This medication works by activating the leptin receptor, which is a protein in the body that helps regulate appetite and metabolism.
The purpose of the study is to see how mibavademab affects body weight in people with this genetic form of obesity. The study will measure changes in body weight and Body Mass Index, which is a calculation using height and weight to assess body size. The treatment will be given over a period of up to 52 weeks, with additional follow-up time afterward. During the study, measurements will be taken to see how body weight, waist size, and body fat change over time. Body fat will be measured using a method called DXA, which is a type of scan that shows how much fat is in different parts of the body.
The study will also look at how the treatment affects hunger and eating behaviors by using questionnaires about hyperphagia, which means excessive hunger and overeating. Safety will be monitored throughout the study by tracking any unwanted effects that occur during treatment. Blood samples will be taken to measure the amount of medication in the body and to check whether the immune system creates any reactions to the treatment. This is an open-label study, which means both the participants and the doctors will know what treatment is being given.
Germany 
