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Mounjaro helped reduce BMI in children

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Lilly submits data for expanded indication to global

regulators

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Study shows sustained blood sugar control over one year

By Sriparna Roy and Maggie Fick

Sept 17 (Reuters) - Eli Lilly's ( LLY ) 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)