Eli Lilly and Novo Nordisk Advance Pediatric Obesity Drug Trials to Unlock New Market Demand

Intelligent Finance APP learned that, as weight-loss drugs gain popularity worldwide, pharmaceutical companies are beginning to seek weight-loss treatments for an increasing number of young patients. According to informed sources, Eli Lilly (LLY.US) is planning to test its diabetes drug Mounjaro on obese patients aged six and above. Meanwhile, Novo Nordisk (NVO.US) is testing Saxenda, a less potent older version of its blockbuster drugs Ozempic and Wegovy, in children under the age of six.

Nadia Ahmad, Eli Lilly's vice president of obesity medical development, said: "We are certainly committed to innovating in this area to address the needs of all affected populations." The pharmaceutical company reportedly began recruiting children aged 12 and above for trials this week.

A spokesperson for Novo Nordisk stated that the company could not comment on when the trial results would be released, as it is currently in a quiet period ahead of the announcement of its third-quarter earnings on November 2 local time. Martin Holst Lange, Novo Nordisk's head of R&D, said in an interview in August that the company plans to conduct more studies on the pediatric population "in the near future."

If either of these two drugs is approved, it will become the world's first weight-loss medication known as a GLP-1 receptor agonist available for young patients in any region globally. To date, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have only approved such treatments for adolescents aged 12 years and above. In July this year, the UK’s National Institute for Health and Care Excellence (NICE) quietly discontinued its review of Wegovy for use in adolescents.

Experts in childhood obesity say the approval of a safe and effective drug is a game changer, especially as rates of obesity among children in the U.S. have tripled in the past decade. About 20% of children aged six and up have obesity, according to the U.S. Centers for Disease Control and Prevention (CDC).

Therefore, for pharmaceutical manufacturers, expanding the channels for younger patients will bring significant economic benefits. A forecast released by Goldman Sachs this week estimates that GLP-1 drugs will generate $100 billion in revenue by 2030, not even including sales to children. Moreover, studies have found that these treatments are only effective if people adhere to them, which means that in many cases, if people want to maintain their weight, they may need to take these medications for life.

However, even if weight-loss drugs are approved for children, it is unclear whether they will be widely used. Limited available information suggests that such drugs are more popular among adults.

According to Komodo Health's analysis of 300 million patients, teenagers accounted for less than 1% of weight-loss prescriptions using new GLP-1 drugs last year. The analysis excluded patients diagnosed with type 2 diabetes, aiming to capture only those taking the medication for obesity. Wegovy was not approved by the FDA for treating adolescent obesity until December 2022, so the use of this drug in teenagers was largely excluded from the study findings.

Earlier this year, the American Academy of Pediatrics (AAP) updated its guidelines to recommend more aggressive interventions for children with obesity, including medical treatments for adolescents. However, this decision is not without controversy. There is still no long-term safety or efficacy data for drugs like Wegovy and Mounjaro in patients with obesity, and questions remain about how these drugs affect adolescents undergoing hormonal changes after puberty.

For younger children, the AAP guidelines do not recommend medication but instead suggest behavioral treatment. Sarah Hampl, who helped develop the guidelines, said this is partly because few studies have been conducted on children at this age. She emphasized that for children of all ages, especially younger ones, providing nutritional counseling and exercise programs is important alongside any medication.

Another issue is cost. Doctors in multiple U.S. states told reporters that commercial insurers are refusing to cover the medication for children. Currently, only about 15 states’ Medicaid programs cover anti-obesity drugs, but eligibility criteria for adolescents tend to be slightly stricter. Except for Rhode Island, nearly all plans require obese children to have attempted and failed at weight loss before covering the drug treatment. Most require individuals to participate in nutritional counseling and exercise programs while taking the medication. Wisconsin’s Medicaid program will not pay for the drug for teenagers with a history of eating disorders.