Who can enter
- Children and adults with Acquired Hypothalamic Obesity
- Age: 4 years and older
The goal of this study is to evaluate how safe and effective the study drug setmelanotide is for weight loss and changes in hunger in patients ≥4 years of age with Acquired Hypothalamic Obesity (HO).
Acquired Hypothalamic Obesity (HO) is a type of obesity caused by an injury to a part of your brain called the hypothalamus. The hypothalamus is responsible for helping to control weight and hunger. Injury or damage to the hypothalamus interferes with the messenger hormones that signal your brain to make you feel hungry or full. Injury to the hypothalamus typically occurs from a tumor, brain surgery, and/or head trauma. In some people this injury can result in uncontrolled weight gain.
The trial sponsor (the company conducting the study, in this case Rhythm Pharmaceuticals) wants to find out if the study drug called setmelanotide (RM-493) can help control body weight and appetite in people with HO. Setmelanotide mimics the natural hormones that help control body weight and appetite. It is hypothesized that setmelanotide helps patients to regulate their body weight and appetite.
The expected duration for participation is approximately 68 weeks, with an 8-week screening period followed by a 60-week (14-month) treatment period with the study drug. In this study, patients will randomly be assigned to receive the study drug or a placebo. The drug is administered once a day by an injection under the skin. After instruction on how to give the injection, parents or patients will be able to perform the daily injections at home.
This study drug is approved for some genetic forms of obesity, and is available to these patients under the name IMCIVREE® (setmelanotide, RM-493). It is approved (i.e., available by prescription) in the US, Europe, Great Britain and Israel to treat people 6 years of age and older with obesity due to these certain types of genetic variations. It is being used in this study in an experimental (investigational) way, meaning that it has not been approved by the FDA or any regulatory authority for patients with acquired hypothalamic obesity.