Pharmaceutical giants will soon begin clinical trials for successful drugs against obesity in children aged six and over.
Eli Lilly, which makes Mounjaro, and Novo Nordisk, which produces Wegovy and Ozempic, will begin recruiting children in the near future, although an exact timeline is unknown.
Wegovy is already approved by the Food and Drug Administration for obese children 12 years and older, but Mounjaro has only received approval for treating diabetes.
It comes despite growing concerns about side effects ranging from stomach paralysis to depression and suicidal thoughts.
If Mounjaro wins approval to give his drug to first-graders, it would cement the U.S.’s status as an outlier when it comes to treating childhood obesity. In Britain, for example, only adults can get their hands on the drugs.
The US is already an outlier in another respect: childhood obesity rates are among the highest in the world, with about one in five classified as obese.
Childhood obesity rates in the US increased by 17% between 2011 and 2020, with those between the ages of 12 and 19 most at risk
Mounjaro, or tirzepatide, helped adult patients lose about 20 percent of their body weight. But data on the safety and efficacy of tirzepatide have not been established in pediatric patients
While Eli Lilly plans to test Mounjaro, also known as tirzepatide, Novo will test an older version of its mega-popular Ozempic and Wegovy injections, called Saxenda.
Lilly’s planned lawsuit was revealed to Bloomberg by an unnamed source with ties to the company.
The U.S. Food and Drug Administration already approved the use of Wegovy in children ages 12 and older in December, making it the first drug of its kind to be approved for adolescents.
According to the Centers for Disease Control and Prevention, nearly 20 percent (about 14.7 million) of children and adolescents under the age of 19 are overweight, while about six percent of them are morbid.
Wegovy and Ozempic are so-called GLP-1 receptor agonists. Their active ingredient is called semaglutide, which promotes weight loss by mimicking the action of GLP-1, or glucagon-like peptide-1, a hormone in the brain that regulates appetite and the feeling of fullness.
The drug Ozempic was initially intended to treat type 2 diabetes. Semaglutide works by helping the pancreas release the right amount of insulin when blood sugar levels are high.
Mounjaro (Lilly’s tirzepatide) is similar to Wegovy and Ozempic, but slightly different. The active ingredient is called tirzepatide and acts not only on the GLP-1 receptors, but also on the hormone glucose-dependent insulintropic polypeptide (GIP), which enhances the positive effects.
Mounjaro has been called the ‘King Kong’ of obesity drugs for use in adults. In a 2022 study published in the New England Journal of Medicine, researchers divided 2,500 overweight and obese people who did not have diabetes into four groups.
They received one of three doses of tirzepatide – 5 mg, 10 mg or 15 mg – or a placebo. More than half of those taking the highest dose lost 20 percent of their body weight, a crucial finding because experts say most obese people need to lose between 15 and 20 percent of their weight to have meaningful health benefits.
The drugs’ popularity has skyrocketed, especially among elites who could pay for the $12,000-a-year injections out of their own pockets. Insurance coverage for adults can be poor and many who would benefit from it cannot afford it.
Children are worse off because insurance does not cover these drugs for them in any capacity and it is not clear when that might change.
U.S. childhood obesity rates are among the highest in the world, with approximately one-fifth of those under the age of 19 qualifying as obese
Another important sticking point besides the costs is the uncertainty about the long-term effects of using the drugs, especially when started so young.
Mounting evidence about the drugs shows that to maintain weight in the long term, people will need to take the drugs consecutively every month for the foreseeable future.
It has already been established that semaglutide can cause potentially serious health consequences such as pancreatitis, intestinal obstructions and gastric paralysis.
Researchers from the University of British Columbia analyzed health insurance claims from US patients prescribed semaglutide or a similar drug called liraglutide between 2006 and 2020.
They found that those taking semaglutide were 9.1 times more likely to develop inflammation of the pancreas, which may require surgery.
They were also 4.22 times more likely to develop an intestinal obstruction, which can be fatal, and had a 3.67 times higher risk of gastroparesis, or “gastric paralysis,” which prevents the passage of food from the stomach to the small intestine is limited.
There is also mounting evidence that patients taking weight loss medications are more prone to depression and developing suicidal thoughts.
Patients include a mother of four who said she felt like she no longer wanted to be here and a nurse who wanted to shoot herself. A total of 265 reports of suicidal ideation and depression have been received by the FDA Adverse Event Reporting System (FAERS), Reuters reports.
They include reports from patients using Wegovy and Ozempic, made by Novo Nordisk, and Mounjaro, made by Eli Lilly.
Signing children up for potentially years of drug use, especially drugs with little known long-term health consequences, has and will continue to deter parents and doctors.
And uptake of the medications approved for adolescents is relatively low. Teenagers aged 13 to 18 were responsible less than 0.5 percent of the number of prescriptions for the four main GLP-1 drugs to patients without diabetes between 2018 and May 2023.