People are turning to alternatives like weight loss medication because weight loss has been shown to be a stressful process that involves strenuous exercise regimens and extreme diets that can result in life-threatening health conditions.
Drugmakers are vying to be the first to market an oral version of the newest class of weight loss medications, which have seen an enormous increase in popularity in recent months as the trend towards using drugs for rapid weight loss continues.
The results of two clinical trials, which were presented at the 2023 American Diabetes Association Scientific Sessions, show how far the pharmaceutical industry has come in developing a pill-based weight loss medication.
Popular medications, such as Mounjaro by Eli Lilly and Ozempic and Wegovy by Novo Nordisk, can cause significant weight loss, but they are all administered via weekly injections.
For some people, a daily pill formulation of a weight-loss medication might be a more agreeable option.
“The nice thing about tablets is that virtually everyone is used to taking a tablet for something, even if it’s just a vitamin. It’s not a big deal,” said Dr Robert Gabbay, the ADA’s chief scientist.
Novo Nordisk has tested an oral version of semaglutide for weight loss in obese or overweight individuals without Type 2 diabetes. Participants in the phase 3 clinical trial lost 15% of their body weight after 68 weeks, similar to the weight loss observed in clinical trials with weekly injections.
The study’s findings are praised as a game changer, as some people prefer pill or tablet forms over injectables due to needle-related concerns.
Dr Mico Guevarra, who heads oral semaglutide research for Novo Nordisk, told NBC that an oral drug for weight loss would give people more options.
“The goal right now is pushing for individualised treatment,” she said. “It really depends on the patient’s goal, the clinician’s goal as well, and kind of meet that and have options as far as what they would like and what would be the best for them.”
According to Erika Arcieri, a spokesperson for Novo Nordisk, the company plans to file for FDA approval for an oral weight loss drug this year. The company also aims to use Rybelsus, a lower-dose version of oral semaglutide, for Type 2 diabetes.
The clinical trial tested a higher dose for weight loss, similar to Ozempic and Wegovy, according to Geuvarra.
However, Dr Shauna Levy, a specialist in obesity medicine at Tulane Bariatric Centre, New Orleans, believes an oral weight loss drug would provide more choices and increase access, but side effects could be more severe than injections, as patients taking Rybelsus often report more side effects, particularly nausea.
“What is the side effect profile?” asked Levy, who was not involved in the research.
Meanwhile, oral semaglutide has been a topic of debate due to its high requirements and side effects. According to Geuvarra, oral semaglutide is well tolerated and has a similar prevalence to injections, with nausea being the most common side effect.
Nevertheless, 80% of participants reported mild to moderate gastrointestinal problems, compared to 46% in the placebo group. About 6% of participants stopped taking the drug before the trial ended due to side effects.
Dr Nadia Ahmad, a physician who leads Eli Lilly’s obesity clinical research team, believes oral weight loss drugs have their place.
“Patients with obesity, in my experience, have had different preferences,” she said.
Furthermore, the phase 2 clinical trial results published in the New England Journal of Medicine showed that participants taking orforlipron lost an average of 9.4% to 14.7% of their body weight after 36 weeks.
The effectiveness is comparable to approved GLP-1s, according to Dr Sean Wharton, a weight loss specialist at Wharton Medical Clinic.
The drug, orforlipron, is taken daily in the morning and can be taken within 30 minutes of eating. Lilly is launching a phase 3 clinical trial to test orforlipron.
Currently, neither oral weight loss drug has demonstrated as much efficacy as Lilly’s tirzepatide, which reduced body weight by 22.5% after 72 weeks.
“I think we’ve gotten spoiled a little bit,” Gabbay said, “because a few years ago we had nothing even as close to as effective.”