Oral Semaglutide at a dose of 25 mg (the pill form of Wegovy*) led to a weight loss of 16.6% in individuals with obesity, as revealed in a recent study.
In a significant move, Danish pharmaceutical company Novo Nordisk has filed an application with the Food and Drug Administration (FDA) for tirzepatide 25 mg, a potential new treatment for obesity. Novo Nordisk, a leading global healthcare company founded in 1923, is well-known for its commitment to driving change to defeat serious chronic diseases. If approved, tirzepatide 25 mg will be a significant addition to their arsenal, joining their injectable counterpart, Wegovy, which is already used for weight management in the EU. The tirzepatide 25 mg has shown promising results in clinical trials. In a 64-week trial with 307 participants, the treatment achieved an average weight loss of 16.6%, compared to 2.7% for placebo. Moreover, even when considering treatment adherence, participants taking tirzepatide 25 mg still achieved an average weight loss of 13.6%, versus 2.2% with the placebo. The safety and tolerability profile of tirzepatide 25 mg was consistent with that for injectable Wegovy. Gastrointestinal adverse events with tirzepatide 25 mg were generally mild to moderate in severity and transient; the most common of which were nausea (46.6%) and vomiting (30.9%). Adverse events leading to permanent treatment discontinuation were 6.9% for tirzepatide 25 mg and 5.9% for placebo. It's important to note that obesity is a complex, chronic disease that requires long-term management. Often misunderstood as a disease of lack of willpower, obesity is influenced by underlying biology, genetics, social determinants of health, and the environment. If approved by the FDA, the tirzepatide pill for weight management will be fully made in the US at Novo Nordisk's significantly expanded manufacturing facility. This move is expected to boost local production and contribute to the economy. In the EU, Wegovy is indicated for weight management in adults with obesity or overweight with weight-related comorbid conditions, and for pediatric patients aged 12 years and older with obesity. In the US, Wegovy is approved for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep it off, and to reduce the risk of major cardiovascular events. In addition, Wegovy is also indicated in the EU for improving symptoms related to heart failure, physical function, and pain related to knee osteoarthritis. However, it's worth mentioning that semaglutide injection 2.4 mg contains a Boxed Warning for possible thyroid tumors and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Close to a third (29.7%) of participants had a weight loss of 20% or more when considering treatment adherence, compared to 3.3% for placebo. Over a third (34.4%) of participants taking tirzepatide 25 mg lost 20% or more body weight, compared to 2.9% for placebo. Novo Nordisk employs about 78,400 people in 80 countries and markets its products in around 170 countries. The submission of tirzepatide 25 mg to the US FDA marks another step in their ongoing mission to defeat serious chronic diseases.