Lilly's Mounjaro Shows Significant Efficacy in Pediatric Type 2 Diabetes, Aiming to Become First GLP-1 Therapy for Adolescents

Eli Lilly's (LLY.US) diabetes drug Mounjaro has shown promising results in a study, helping children as young as 10 control blood sugar and lose weight. The study may provide doctors with a new tool to combat childhood diabetes.

This injectable drug, which has been widely used by adult diabetes patients, also shows benefits in the adolescent patient population. Research results presented at the European Association for the Study of Diabetes conference in Vienna indicate that the drug can reduce blood glucose levels in adolescent patients by an average of about 2%, and after one year of treatment, patients experience weight loss exceeding 10%.

Eli Lilly said that it has submitted the results of this study, which covered about 100 children aged 10 to 17, to global pharmaceutical regulatory authorities in the hope of expanding the indications for Mounjaro. If approved, it will become the first blockbuster GLP-1 drug specifically targeting adolescent patients with type 2 diabetes. Type 2 diabetes is often associated with being overweight.

Tamara Hannon, Professor of Pediatrics at Indiana University School of Medicine and Director of the Clinical Diabetes Program, pointed out that type 2 diabetes diagnosed in childhood progresses more rapidly than in adults, and current treatments do not always achieve ideal outcomes.

Hannon, who is also the lead researcher of this study, said the findings were simultaneously published in The Lancet. "I really hope there will be such a treatment option available, and I expect the market demand to be very strong," she stated, adding that the drug "could help alter the long-term health trajectory of adolescents with this complex condition."

Eli Lilly and its GLP-1 competitor Novo Nordisk (NVO.US) have both initiated clinical trials of their injectable drugs in children as young as 6 years old. With the significant rise in obesity and diabetes rates among elementary school students, various medical groups are calling for more proactive intervention measures. Currently, Novo Nordisk's obesity treatment drugs Wegovy and Saxenda have been approved in the U.S. and Europe for use in individuals aged 12 and above; however, its diabetes treatment drug Ozempic has not yet been approved for pediatric use.

Eli Lilly's Mounjaro and Zepbound are currently only available for adult patients.

The Incidence of Diabetes in Adolescents Continues to Rise

Data from the U.S. Centers for Disease Control and Prevention (CDC) shows that the number of newly diagnosed type 2 diabetes cases among people under 20 in the United States doubled between 2002 and 2018. A recent report released by the agency also found that nearly one-third of adolescents have prediabetes symptoms.

According to the CDC, the rate of childhood obesity continues to rise, with approximately 20% of children aged 6 and above affected by obesity. In the American Academy of Pediatrics (AAP) 2023 guidelines, weight-loss medications were included as a treatment option for childhood obesity, but behavioral therapy is still recommended as the primary approach for younger patients.

Although experts in the field of pediatric obesity believe that safe and effective drugs could bring breakthrough changes to treatment, the use of such drugs in children and adolescents remains controversial. Some doctors and parents question whether these drugs might have adverse effects on adolescents whose bodies are still developing.

The study found no difference in growth and development rates between children using Mounjaro and those using a placebo. About 15% of children using the drug experienced hypoglycemia symptoms, compared to 6% in the placebo group. Other treatment-related side effects included diarrhea, nausea, vomiting, and abdominal pain, which mainly occurred during the phase of dose escalation. However, very few children discontinued the study due to these complications.

Despite this, many questions remain about the risks and benefits of using GLP-1 drugs in children. Robert F. Kennedy Jr., the U.S. Secretary of Health and Human Services, who has pledged to curb the "over-medicalization" of American children, stated that these drugs should not become a "first-line intervention for 6-year-olds."

Calley Means, one of Little Kennedy's chief advisors, said that such drugs are being "forcefully promoted" to American children and drew attention to a recent study on the financial ties between members of the AAP and manufacturers of obesity treatment drugs.

Eli Lilly and Company conducted this study, enrolling pediatric patients whose diabetes could not be effectively controlled through existing treatments, including insulin and metformin. The study showed that over 80% of patients using the highest dose of Mounjaro reached their blood sugar control targets.

Researchers said that the patient's weight continued to drop throughout the study period, without reaching a plateau.