By Sriparna Roy and Maggie Fick
(Reuters) -Eli Lilly’s Mounjaro helped children and adolescents aged 10 to 17 years with type 2 diabetes manage their blood sugar better and lose weight, according to trial results presented at a medical meeting on Wednesday.
The Lilly-sponsored study is the first to assess tirzepatide, the active ingredient in its blockbuster diabetes GLP-1 drug Mounjaro, in young children.
Treatment options for children with type 2 diabetes for controlling blood sugar are limited to metformin and insulin. Danish rival Novo Nordisk’s older GLP-1 drug Victoza is also approved for children who are 10 years of age and older with type 2 diabetes.
Lilly said it has submitted the new data to global regulators to support expanded use of Mounjaro for children.
The drug helped patients significantly reduce their BMI, a measure of body fat based on height and weight that helps to define if a person is overweight or obese.
“We don’t think of this based on its commercial opportunity. This is about taking a meaningful medicine that’s made a great difference for adults, and showing that it has similar encouraging results in kids,” Kenneth Custer, president of Lilly’s cardiometabolic health division, told Reuters in an interview.
A total of 146 participants were screened and 99 were randomly assigned to receive either a 5 milligram or 10 milligram dose of Lilly’s drug, or a placebo, once a week in the late-stage trial.
Mounjaro helped reduce the levels of A1C – a measure of blood sugar over time – by an average of 2.2% in children and adolescents, compared to placebo, meeting the main goal of the study.
Patients who received the 5mg dose showed a 7.4% reduction in BMI, while those on the 10 mg dose saw a drop of 11.2%. That compares with a 0.4% reduction in placebo groups at 30 weeks.
The trial results were presented at the European Association for the Study of Diabetes meeting in Vienna and published in The Lancet.
The impact on blood sugar control was sustained over the one-year trial period, and improvements in BMI continued through the year and did not plateau, the authors of the study said.
Lilly’s drug helped patients improve HbA1c, a measure of blood sugar control, as well as blood sugar after fasting.
At the start of the study, all the participants had HbA1c above 6.5%, classifying them as type 2 diabetes patients.
At 30 weeks, 79% of children taking tirzepatide saw their HbA1c drop below 6.5%, indicating they were no longer in the diabetes range, while more than half (53%) saw an even steeper fall in their HbA1c to under 5.7%, which is considered normal or below the prediabetes range. By comparison, only 29% and 14% of children in the placebo group reached the same milestones.
Two patients on the 5mg dose discontinued the study due to side effects, but the safety of the drug was consistent with that reported in adults. The most common side effects were gastrointestinal, mild to moderate in severity.
(Reporting by Sriparna Roy in Bengaluru and Maggie Fick in Vienna; Editing by Anil D’Silva)
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