The kids are alright — on GLP-1s, that is.
A new study found that blockbuster treatments like Mounjaro and Zepbound can dramatically lower blood sugar and body weight in children as young as 10 with Type 2 diabetes.
The data could help pave the way for younger patients to access the shots, as drugmaker Eli Lilly seeks to expand its approval beyond adults. And the stakes couldn’t be higher.
In 2002, 9 out of every 100,000 young Americans were diagnosed with Type 2 diabetes. By 2018, that number had doubled to 18 per 100,000, according to the CDC.
If the trend continues, the number of children and adolescents with the chronic disease is projected to soar from 28,000 in 2017 to 220,000 by 2060.
“Type 2 diabetes in children and teens is increasing at an alarming rate, yet treatment options are limited, and this patient population remains underserved,” Dr. Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said in a statement.
“By undertaking this research, we can better support children and adolescents living with this condition.”
GLP-1 goes junior
The trial focused on tirzepatide — the active ingredient in the weight loss drug Zepbound and the Type 2 diabetes treatment Mounjaro.
It works by mimicking two hormones naturally produced by the body that reduce appetite, slow digestion and lower blood sugar.
To gauge its safety and effectiveness in young people, scientists recruited 99 patients between the ages of 10 and 17 who had poorly controlled obesity and Type 2 diabetes despite being on treatments like metformin and/or insulin.
Participants received either 5 milligrams or 10 mg of tirzepatide or a placebo weekly for 30 weeks.
By the end of the study, those treated with tirzepatide saw an average A1C reduction — a key measure of blood sugar control — of 2.2%, compared to just .05% for the placebo group.
In fact, 71% of patients on 5 mg and 86% on 10 mg lowered their A1C to 6.5% or less, the threshold considered below the diabetes range. Only 28% of the placebo group reached this target.
The treatment also improved body mass index (BMI).
Patients on 5 mg and 10 mg doses saw reductions of 7.4% and 11.2%, respectively, compared to just 0.4% for those on a placebo. These results came from a baseline BMI average of 35.5, which falls into the obese category.
The benefits to blood sugar control and BMI were sustained through 52 weeks and showed no signs of plateauing.
“Tirzepatide is the first drug used for Type 2 diabetes in this age group that has shown sustained clinically-meaningful, BMI-lowering effects,” the study authors wrote.
The treatment’s safety profile was similar to what’s been seen in adults, with the most common side effects being mild to moderate gastrointestinal issues that generally lessened over time. Two patients on the 5 mg dose discontinued treatment.
“Youth living with Type 2 diabetes often face a more aggressive disease course, and in many instances, first-line treatments like metformin and basal insulin fail to control their A1C adequately,” Dr. Tamara Hannon, director of the Clinical Diabetes Program at Indiana University and lead trial investigator, said in a statement.
“These results offer a promising opportunity to help shift the long-term health trajectory for young people living with this complex condition,” she added.
Lilly has submitted the trial results to global regulators, aiming to expand Mounjaro’s approval to include younger patients.
So far, the FDA has approved three GLP-1 drugs for treating Type 2 diabetes in patients 10 and older, and two for treating obesity in people ages 12 through 17.