SAN DIEGO — Drugmakers are racing to be the first to market with an oral version of the newest class of weight loss drugs that have soared in popularity in the past year.
Results of two clinical trials, presented here at the 2023 American Diabetes Association Scientific Sessions, point toward the progress drug companies have made in the development of a weight loss drug in pill form.
Popular drugs, including Eli Lilly’s Mounjaro and Novo Nordisk’s Ozempic and Wegovy, can produce significant weight loss, but all are given as weekly injections.
A weight loss drug in the form of a daily pill may be a more palatable option for some people.
“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.
On Sunday, Novo Nordisk presented findings looking at an oral version of semaglutide — the active ingredient in Ozempic and Wegovy — for weight loss in people who are obese or overweight, and do not have Type 2 diabetes. Participants in the phase 3 clinical trial lost 15% of their body weight, on average, after 68 weeks. The findings were simultaneously published in The Lancet.
The weight loss seen in the trial was on par with what Novo Nordisk reported in clinical trials with people taking a weekly injection of semaglutide over the same time period.
“It really is a game changer,” Gabbay said.
Some people prefer taking their medicine in the form of a pill or tablet, instead of an injectable, because they are afraid of needles, he said.
Dr. Mico Guevarra, who heads oral semaglutide research for Novo Nordisk, told NBC News that an oral drug for weight loss would give people more options.
“The goal right now is pushing for individualized 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.”
An oral weight loss drug likely won’t be on the market this year. Erika Arcieri, a spokesperson for Novo Nordisk, said the company planned to file for Food and Drug Administration approval sometime in 2023.
More on weight loss drugs
A lower-dose version of oral semaglutide from Novo Nordisk, called Rybelsus, is already approved for Type 2 diabetes.
The dose tested in the clinical trial for weight loss was higher. It’s similar to how Ozempic, which is a slightly lower dose of semaglutide, is approved for diabetes, while Wegovy, a higher dose of the drug, is approved for weight loss, Guevarra said.
Dr. Shauna Levy, a specialist in obesity medicine at the Tulane Bariatric Center in New Orleans, agreed that an oral weight loss drug would likely give people more choices and increase access, but side effects could be more severe than what’s been seen with injections.
Patients taking Rybelsus, she said, tend to report more side effects compared with the injection, particularly nausea.
“What is the side effect profile?” asked Levy, who was not involved in the research.
Adherence is also a concern: Oral semaglutide is supposed to be taken daily, in the morning, on an empty stomach. “There’s a lot of requirements,” she said.
Guevarra said the oral semaglutide was well-tolerated and the prevalence of side effects was similar to the injection. Nausea was the most common side effect reported, she said. Overall, 80% of people who got the oral drug reported gastrointestinal problems, which were described as mild to moderate, compared with 46% of people in the placebo group. About 6% of people chose to stop taking the drug before the trial ended because of side effects.
Regardless, researchers in the pharmaceutical industry say oral weight loss drugs have their place.
“Patients with obesity, in my experience, have had different preferences,” said Dr. Nadia Ahmad, a physician who heads Eli Lilly’s obesity clinical research.
Lilly presented results on an oral weight loss drug at the conference on Friday. Participants taking the drug, called orforlipron, lost an average of 9.4% to 14.7% of their body weight, depending on the dose given, after 36 weeks, according to the phase 2 clinical trial results, which were published in the New England Journal of Medicine.
The effectiveness is “comparable to approved GLP-1s,” said lead study author Dr. Sean Wharton, a weight loss specialist at Wharton Medical Clinic, which focuses on weight loss and diabetes management in Burlington, Ontario, who presented the findings Friday.
Like oral semaglutide, orforlipron is taken daily, in the morning, Wharton said. Unlike oral semaglutide, however, orforlipron can be taken within 30 minutes of eating.
Lilly is launching a phase 3 clinical trial testing orforlipron, according to clinicaltrials.gov.
So far, neither of the oral weight loss drugs have demonstrated as high of an efficacy as Lilly’s tirzepatide, which was shown to reduce body weight, on average, by 22.5% after 72 weeks.
Gabbay said the weight loss shown is still significant.
“I think we’ve gotten spoiled a little bit,” he said, “because a few years ago we had nothing even as close to as effective.”
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