Targeting the youth market! Eli Lilly (LLY.US) Mounjaro study shows significant results, impacting the qualification for the first children's GLP-1 glucose-lowering drug.

Eli Lilly's diabetes drug Mounjaro showed promising results in a study, helping children as young as 10 years old control blood sugar and lose weight. This study may provide doctors with a new tool to combat childhood diabetes. The injectable drug, widely used by adult diabetes patients, has also shown benefits in the adolescent patient population. Results presented at the European Diabetes Research Association meeting in Vienna showed that the drug lowered average blood sugar levels in adolescent patients by about 2%, with a weight loss of over 10% after a year of treatment. Eli Lilly has submitted the results of this study, which included about 100 children aged 10 to 17, to global regulatory authorities in hopes of expanding the indications for Mounjaro. If approved, it will be the first heavyweight GLP-1 drug specifically for type 2 diabetes adolescent patients, often associated with obesity. Tamara Hannon, professor of pediatrics at Indiana University School of Medicine and director of the Clinical Diabetes Program, stated that the progression of type 2 diabetes in childhood is faster than in adult patients, and existing treatment methods do not always achieve optimal results. Hannon, who is also the lead investigator in this study, noted that she is hopeful for this treatment option. She believes there will be a high demand in the market, as this drug "helps to change the long-term health trajectory of adolescents with this complex disease." Eli Lilly and its competitor in the GLP-1 field, Novo Nordisk A/S Sponsored ADR Class B, have conducted clinical trials of their injectable drugs in children as young as 6. With the rising rates of obesity and diabetes among school-aged children, healthcare groups are calling for more proactive interventions. Currently, Novo Nordisk A/S Sponsored ADR Class B's obesity drugs Wegovy and Saxenda have been approved in the US and Europe for ages 12 and above; however, their diabetes drug Ozempic has not been approved for use in children. Eli Lilly's Mounjaro and Zepbound are currently only approved for adult patients. Rising rates of diabetes in adolescents Data from the Centers for Disease Control and Prevention (CDC) shows that between 2002 and 2018, the number of new cases of type 2 diabetes among individuals under 20 in the US doubled. A recent report from the agency also found that nearly one-third of adolescents have prediabetes symptoms. According to the CDC, childhood obesity rates are also on the rise, with around 20% of children aged 6 and above affected by obesity. The American Academy of Pediatrics (AAP) included weight-loss medications in its 2023 guidelines for the treatment of childhood obesity, but still recommends behavioral therapy for younger patients. While experts in pediatric obesity believe that safe and effective medications could bring groundbreaking changes to treatment, the use of such drugs in children and adolescents remains controversial. Some doctors and parents question whether these drugs may have adverse effects on adolescents whose bodies are still developing. The study found that children using Mounjaro did not have differences in growth rates compared to those using a placebo. About 15% of children using the drug experienced symptoms of hypoglycemia, compared to 6% of children using the placebo. Other treatment-related side effects included diarrhea, nausea, vomiting, and abdominal pain, which mainly occurred during the dose escalation phase, but the number of children withdrawing from the study due to these complications was very low. Despite this, there are still many questions about the risks and benefits of using GLP-1 drugs in the pediatric population. US Department of Health and Human Services Secretary Robert F. Kennedy has pledged to curb the "overmedicalization" of American children and stated that these drugs should not be the "first-line intervention for 6-year-olds." One of Kennedy's chief advisors, Calley Means, stated that these drugs are being "aggressively promoted" to American children and called attention to recent research on financial relationships between AAP members and manufacturers of obesity treatment drugs. The study conducted by Eli Lilly included children who could not effectively control diabetes using existing treatments (including insulin and metformin). The study showed that over 80% of patients who used the highest dose of Mounjaro achieved their blood sugar control goals. Researchers noted that patients' weight continued to decrease throughout the study period, with no plateau in sight.