Somatrogon vs Genotropin for Short Stature

(MISSION Trial)

This trial tests two treatments to help children who are shorter than average for their age. It compares Somatrogon, a new growth hormone therapy given once a week, to Genotropin, a daily growth hormone therapy. The goal is to determine which treatment better aids children born smaller than expected (Small for Gestational Age) or those with no known reason for their short stature (Idiopathic Short Stature) in growing taller. Children who are pre-pubertal, diagnosed with either SGA or ISS, and have not previously received growth hormone treatment may be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

The trial requires that you stop taking certain medications, such as growth-promoting therapies, some psychiatric medications, and certain hormone therapies. If you're on hormonal replacement therapy, you must have been on a stable regimen for at least three months before the trial.

Research has shown that Somatrogon, a weekly growth hormone, is generally well-tolerated. Several studies have found its safety comparable to daily growth hormone treatments like Genotropin. For instance, one study found that both Somatrogon and daily treatments had similar effects on height and safety over six months. Another study demonstrated that Somatrogon was safe and effective in everyday use, though results varied slightly. Despite some early concerns, overall, Somatrogon has proven to be as safe as daily growth hormone treatments.¹²³⁴⁵

Unlike traditional treatments for short stature that require daily injections, Somatrogon is unique because it is administered just once a week. This makes it a more convenient option for patients, potentially improving adherence and quality of life. Researchers are excited about Somatrogon because it offers a new delivery method using a multi-dose disposable prefilled pen, which is designed for easy self-injection. This could make managing growth hormone deficiency much simpler and less burdensome for patients and their families.

This trial will compare Somatrogon, given once weekly, with Genotropin, given daily, for children with growth hormone issues. Research has shown that Somatrogon helps children grow taller, with studies finding that children taking Somatrogon grew more over 12 months compared to those taking daily somatropin. Genotropin, a daily growth hormone treatment, has also been proven to help children grow taller. Both Somatrogon and Genotropin are effective and safe, making them good options for promoting growth in children.¹⁴⁵⁶⁷