The first trials of glucagon-like peptide-1 (GLP-1) receptor agonists in adolescents diagnosed with overweight and obesity are underway in Russia, according to the press service of the St. Petersburg-based pharma manufacturer Geropharm.
“The original semaglutide drug from Novo Nordisk, which is unavailable in Russia, has only a temporarily registered indication for treating this patient group. Similar foreign studies of tirzepatide are still in early stages,” the press service told GxP News.
The company has enrolled 380 adolescents in the Phase 3 clinical trial of the subcutaneous drug tirzepatide (Sejaro, a generic version of Eli Lilly’s Mounjaro). The trial to evaluate the drug’s efficacy and safety is taking place at 24 medical institutions, primarily in St. Petersburg. Initial results are expected in 2026.
About four months ago, Phase 3 of a clinical trial for semaglutide (Semavic, a generic version of Novo Nordisk’s Ozempic) began with 400 adolescents across 28 medical institutions. “The vast majority are reaching target body weight values during treatment, and not many participants have reported side effects ,” the company said, adding they plan to complete the trials next year.
It is also noted that current treatment for adolescent obesity involves daily injections of liraglutide or orlistat, which is “associated with a number of limitations and risks.” None of the “more effective, convenient, and accessible” GLP-1 agonists currently have registered indications for use in children.
According to the National Medical Research Center for Endocrinology of the Ministry of Health, over 600,000 children in the country are diagnosed with obesity, and 18.8% are overweight. The actual number may reach 6 million. Childhood obesity causes irreversible consequences for the development of the musculoskeletal, cardiovascular, and reproductive systems. Excess weight multiplies the risk of heart attack, stroke, and type 2 diabetes by the age of 30-40.