About this study
Hypothalamic obesity is a serious health problem. It happens when a part of the brain called the hypothalamus is hurt. This can happen after surgery, radiation, or an injury. The hypothalamus helps control hunger and how the body uses energy. It works through a brain pathway called MC4R. MC4R acts like a hunger switch and helps tell the body when it is full and how much energy to use. When the hypothalamus is damaged, the MC4R pathway does not work the right way.
When MC4R does not work properly, the brain has trouble controlling hunger and how the body uses energy. People may feel hungry more often, eat more, and gain weight very quickly. It can also be very hard for them to lose weight.
There are no approved medicines to treat hypothalamic obesity. Because of this, doctors need better treatments.
This study tests a medicine called bivamelagon. This medicine was made to work on the MC4R pathway. It may help improve hunger control and help people manage their weight.
People in this study have already taken bivamelagon in an earlier study. The main goal of this study is to see if the medicine is safe to use for a long time. The study will also look at whether the medicine continues to help with weight and overall health.
Participants will take bivamelagon by mouth every day for up to 2 years. They will visit the clinic about every 12 weeks. At these visits, doctors will check weight, height, and body size. Blood and urine tests will help check safety. Some participants will have x-rays of the hand or wrist and scans to look at body fat and bone health. Participants will also answer questions about daily life and mood. The study team will help if any side effects happen.
This study will help researchers learn if bivamelagon is safe to use long term and if it may help control weight. The results may help guide future studies and new treatments.
Eligibility overview
- Hypothalamic obesity
- Completed previous study with bivamelagon (LG-MCCL005) and tolerated the drug
- Age 12 years or older