Minneapolis, MN—Liraglutide 3.0 mg is approved by the FDA as an adjunct to a reduced-calorie diet and increased physical activity to aid weight management in adults with obesity. Now, a new study suggests that the drug also could be helpful for adolescents who struggle to take off pounds.

The industry-sponsored randomized, controlled trial was accepted for presentation at ENDO 2020, the Endocrine Society’s annual meeting and published by The New England Journal of Medicine.

“The results of this clinical trial suggest that liraglutide 3.0 mg given once daily along with lifestyle therapy improves body-mass index (BMI) standard deviation score (BMI SDS) and other measures of BMI and body weight among adolescents with obesity who have had difficulties in managing their weight with lifestyle therapy alone,” said study author Aaron S. Kelly, PD, a professor in the Department of Pediatrics and a codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota Medical School in Minneapolis.

In the trial, which was conducted at 33 sites in the United States, Mexico, Belgium, Sweden, and the Russian Federation, Dr. Kelly and his colleagues focused on obese adolescents between ages 12 and 17 years who had not responded to lifestyle therapy.

Changes over time in BMI SDS, which reflects the relative weight-to-height ratio adjusted for age and sex, were tracked, and researchers also evaluated changes from baseline in other weight-related outcomes.

Over a 12-week run-in period, all 251 participants received lifestyle therapy that involved counseling in healthy nutrition and physical activity for weight management, with 125 of them then receiving SC liraglutide 3.0 mg (or the highest dose tolerated) once daily. The remaining 126 participants received placebo once daily.

Lifestyle therapy for participants in both groups continued over the 56-week treatment period and the 26-week off-treatment follow-up. In the treatment group, of those receiving liraglutide, 101 participants remained through week 56 and 99 completed through week 82. In the placebo group, 100 remained through week 56 and 99 completed at week 82.

Results indicate that, by week 56, participants who had received liraglutide showed significantly reduced BMI SDS and greater improvements in body weight, BMI, waist circumference, and other weight-related outcomes versus those who received placebo. No significant differences in blood pressure, fasting lipids, fasting plasma glucose, or hemoglobin A1c were documented at that point, however.

The report notes that, at week 82, after 26 weeks of drug discontinuation but continued lifestyle therapy, participants who had received liraglutide during the 56-week treatment period had a greater increase in BMI SDS than those in the placebo group.

Researchers add that the safety profile of liraglutide was similar to the adult experience, with no reported unexpected safety concerns or severe hypoglycemia. Adolescents taking liraglutide reported more gastrointestinal side effects (64.8%) than those taking placebo (36.5%) and few serious adverse events—three versus five events, respectively.

No apparent effects on growth or pubertal development were identified, and mental-health questionnaire results at 52 weeks were similar in both groups, the authors note.

“In adolescents with obesity, the use of liraglutide (3.0 mg) plus lifestyle therapy led to a significantly greater reduction in the BMI standard-deviation score than placebo plus lifestyle therapy,” the authors conclude.

“Obesity is a serious, chronic, progressive disease affecting around 107.7 million children and adolescents worldwide and is associated with an increased risk of developing other health problems,” Dr. Kelly added. “Over 70% of children with obesity before puberty maintain obesity as adults. Effective treatment options for adolescents with obesity are limited, and lifestyle therapy, the typical first treatment, often yields suboptimal responses. In adolescents with obesity, we need additional treatment options that we can use along with lifestyle therapy.”

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