Interim Study Results on Obesity in Adolescents Released

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Geropharm has revealed preliminary results from clinical trials of semaglutide (Semavik Next) and tirzepatide (Sejaro), which are aimed at treating obesity in adolescents aged 12–17 years.

Geropharm is the first Russian company to initiate studies of GLP-1 class drugs in adolescent patients. The research on tirzepatide use in adolescents is also the first of its kind globally, according to newstula.ru.

According to the World Health Organization, more than 390 million children worldwide suffer from overweight, with 160 million of them being obese. Since 1990, the prevalence of the disease among adolescents has quadrupled. In Russia, according to Ministry of Health data, the diagnosis of "obesity" has been established in more than 480,000 schoolchildren. Childhood obesity is associated with an increased risk of developing type 2 diabetes, cardiovascular diseases, liver and kidney disorders, as well as musculoskeletal and reproductive system pathologies in adulthood.

Currently, GLP-1 class drugs for weight control are only approved for adults. In the treatment of pediatric obesity, liraglutide and orlistat are used, but both require daily administration. Additionally, these treatment regimens may be associated with more frequent side effects and lower efficacy compared to newer generation drugs.

The clinical trials began in the fall of 2025. They involve around 800 adolescents and are conducted in more than 50 research centers located in 18 cities across Russia. Over the course of a year, participants receive therapy under the supervision of pediatric endocrinologists, track changes in body weight and other health indicators, and follow recommendations on nutrition and physical activity. The project involves medical organizations accredited by the Russian Ministry of Health, including the Federal State Budgetary Institution "National Medical Research Center for Endocrinology named after Academician I. I. Dedov" and I. M. Sechenov First Moscow State Medical University.

At the start of the trials, the average body weight of the adolescents was 95–97 kg, with an average body mass index of 34.1. Most participants had grade II–III obesity. Non-alcoholic fatty liver disease was detected in one in five adolescents, lipid profile abnormalities in one in four, and clinical hypertension in one in ten.

Preliminary results of the Semavik Next and Sejaro studies show that, after the first six months of treatment, the body mass index of a significant portion of participants decreased by approximately 20%. The company provided an example of weight reduction from 96 kg to 75 kg. About 70% of adolescents changed their eating habits, and one-third became more physically active and started regular sports. Additionally, the prevalence of co-occurring chronic diseases decreased, and the safety profile of the drugs was comparable to data previously obtained from studies involving adults.

Geropharm CEO Pyotr Rodionov emphasized that severe obesity in childhood often leads to the development of chronic diseases by early adulthood. He noted that the first Russian studies of semaglutide and tirzepatide in adolescents confirm the possibility of weight loss and reduction of risks associated with diabetes, liver, and vascular conditions. The company intends to bring the results of the studies to practical application to increase the availability of effective therapy for this category of patients.