What if the treatment of obesity could be as simple as taking an effective pill? This idea has long instilled hope in the hearts of many Americans, as over 40% of the population is classified as obese. However, it has also faced criticism from proponents of wider weight acceptance. Nevertheless, this hope might soon become a reality.
Final results from two studies released on Sunday night suggest that high-dose oral versions of the weight-loss drug Wegovy may be just as effective as the popular injections in reducing weight and improving overall health. These potent tablets also show promise for individuals with diabetes, a group known for their difficulties in losing weight.
The pharmaceutical company Novo Nordisk intends to seek approval from the U.S. Food and Drug Administration for these pills later this year. Dr. Daniel Bessesen, an endocrinology specialist at Denver Health who treats patients with obesity, but was not directly involved in the research, points out that when given a choice between a pill and an injection, most people prefer the former.
Bessesen points out that the assumption here is that both methods of taking the medication, i.e., pill and injection, are equally effective, easily accessible, and affordable. According to him, these factors are crucial considerations for people seeking treatment.
While there have been other weight-loss pills available, none of them have achieved the significant weight reductions observed with injected drugs like Wegovy. Therefore, individuals with obesity will be delighted to have an oral option that is equally effective. Dr. Katherine Saunders, a clinical professor of medicine at Weill Cornell Health and co-founder of Intellihealth, a company specializing in obesity treatment, expressed her enthusiasm for this development.
Novo Nordisk already markets Rybelsus, an oral version of semaglutide, which is approved for diabetes treatment. Semaglutide is the same medication used in the diabetes drug Ozempic and Wegovy. Rybelsus is available in doses of up to 14 milligrams.
Results from two rigorous clinical trials presented at the American Diabetes Association’s annual meeting examined the effects of high doses of oral semaglutide, ranging from 25 milligrams to 50 milligrams, on weight reduction, blood sugar levels, and other health indicators.
In a 16-month study involving approximately 1,600 individuals who were overweight or had obesity and were already receiving treatment for Type 2 diabetes, it was found that the high-dose daily pills of oral semaglutide demonstrated significantly better results in lowering blood sugar compared to the standard dose of Rybelsus. Moreover, participants on the higher doses experienced weight loss ranging from 15 pounds (6.80 kilograms) to 20 pounds (9.07 kilograms) from a baseline weight of 212 pounds (96.16 kilograms), whereas those on the lower dose achieved approximately 10 pounds (4.54 kilograms) of weight loss.
Another 16-month study was conducted on over 660 adults who were overweight or had obesity and at least one related health condition, excluding diabetes. The results showed that the 50-milligram daily pill of oral semaglutide helped individuals lose an average of about 15% of their body weight, equivalent to approximately 35 pounds (15.88 kilograms), compared to around 6 pounds (2.72 kilograms) in the placebo group.
The weight loss achieved through the high-dose daily pills of oral semaglutide was found to be “notably consistent” with the weight loss observed in individuals receiving weekly injections of the highest dose of Wegovy, as stated by the study authors.
However, it is important to note that there were side effects associated with the use of oral semaglutide. Approximately 80% of the participants who received any dosage of oral semaglutide reported mild to moderate intestinal issues, including nausea, constipation, and diarrhea.
In the obesity trial involving the 50-milligram dosage, there was evidence of higher rates of benign tumors in individuals who took the drug compared to those who received a placebo. Additionally, around 13% of the participants who took the drug reported experiencing “altered skin sensation,” such as tingling or increased sensitivity.
Medical experts anticipate that the oral pills will gain popularity, particularly among individuals who desire to lose weight but have a fear of needles. Moreover, tablets offer the advantage of being more portable than injection pens and do not require refrigeration for storage.
However, the pills may not necessarily be a superior choice for the hundreds of thousands of individuals already using injectable versions such as Ozempic or Wegovy, according to Dr. Fatima Cody Stanford, an expert in obesity medicine at Massachusetts General Hospital. She mentioned that many people appreciate the convenience of taking a medication once a week and do not exhibit significant hesitancy towards receiving injections.
Furthermore, Dr. Stanford noted that some patients may actually prefer the shots over the new pills, as the pills need to be taken 30 minutes before eating or drinking in the morning.
Paul Morer, a 56-year-old employee at a New Jersey hospital system, has successfully lost 85 pounds using Wegovy and aims to lose an additional 30 pounds. Despite the availability of pills, he intends to continue with the weekly injections as they have become a seamless part of his routine, and he barely feels the needle, considering it a non-issue.
However, critics express concerns that the availability of a weight-loss pill could further pressure obese individuals to use it, exacerbating social stigma against those who are unable or choose not to lose weight. Tigress Osborn, chair of the National Association to Advance Fat Acceptance, highlights that this narrative perpetuates the idea that one’s body is inherently wrong and must be changed.
Nevertheless, Novo Nordisk remains optimistic about the potential popularity of a higher-dose pill that can address both diabetes and obesity. Sales of Rybelsus, their existing oral medication, reached approximately $1.63 billion in the past year, doubling the 2021 figure.
Other pharmaceutical companies are also developing oral versions of drugs with similar efficacy to Eli Lilly and Co.’s Mounjaro, an injectable diabetes drug expected to receive approval for weight loss. Promising mid-stage trial results have been reported for oral pills such as orforglipron, designed to treat obesity and overweight patients with and without diabetes. Pfizer has also released mid-stage results for dangulgipron, an oral drug for diabetes taken twice daily with food.
Novo Nordisk has not yet disclosed the cost of their high-dose oral pills or how they plan to ensure sufficient manufacturing capacity to meet the demand. Despite the increasing popularity, the availability of injectable doses of Wegovy is expected to remain limited until at least September, according to company officials.