New Studies Show Oral Weight Loss Drugs Work

For people who are overweight or obese but are put off by popular weight loss drugs because they need to be injected, there was promising news Sunday out of the American Diabetes Association’s annual conference.ozep

In clinical trials, the pill forms of the popular weight-loss and type 2 diabetes drugs Ozempic and Wegovy worked very well at helping people lose up to 15% of their body weight over the course of nearly 6 years. That’s the equivalent of a 200-pound person losing 30 pounds. The data were presented at the conference and, at the same time, published in the journal The Lancet.

The results from the two new studies showed that the new pill forms needed higher amounts of the active ingredient, semaglutide, compared to other options already on the market. Semaglutide works by helping the brain regulate appetite and food cravings.

Because the FDA approves drugs for specific uses and in specific populations, two separate studies were done for the new pill versions of semaglutide. One study evaluated the pills among people who were overweight or obese, and the second study evaluated the pills among people who had type 2 diabetes. Both trials compared the effectiveness and side effects of a placebo pill with one that contains 50 milligrams of semaglutide. The type 2 diabetes study also evaluated 14-milligram and 25-milligram semaglutide pills, and showed that higher doses were more effective.

A spokesperson for Novo Nordisk, the company that makes Ozempic, Wegovy, and the new pill forms, told NBC News that the company plans to file for FDA approval this year, but the pill versions likely won’t be on the market until at least 2024.

“I suspect there are a lot of people that are not using these treatments because it requires an injection,” Robert Gabbay, MD, PhD, chief scientific and medical officer for the American Diabetes Association, told The New York Times. “If you could say, ‘Well, actually, it doesn’t,’ that’s big.”

Results of a trial of another weight loss drug in pill version, called orforglipron, were also published last week and presented at the American Diabetes Association’s annual conference in San Diego. Made by Eli Lilly, orforglipron helped people who were overweight or obese achieve up to a 15% weight loss in 36 weeks.

Orforglipron works like semaglutide by mimicking hormones that help the brain regulate appetite. The orforglipron trial results among overweight and obese people appeared Friday in The New England Journal of Medicine, and trial results among people with type 2 diabetes appeared Friday in The Lancet. The Reuters news agency called the publication of the results a “marker in the race to develop effective oral obesity drugs.”

The popularity of injectable semaglutide has caused a stir in the U.S. drug market, with shortages recently of both Ozempic and Wegovy, as well as safety warnings from the FDA about drug knockoffs. The market for weight loss and type 2 diabetes medicines continues to grow. More than 100 million people in the U.S. are obese, and that number will increase to include half of all people in the U.S. by 2030, according to the American Diabetes Association, which also said nearly 90% of the 37 million people in the U.S. who have diabetes are obese or overweight.

SOURCES:

NBC News: “Effective pills for weight loss, including an oral version of Ozempic, are on the horizon.”

The New York Times: “A Pill Form of Ozempic Is on the Horizon.”

The Lancet: “Oral semaglutide 50 mg taken once per day in adults with overweight or obesity (OASIS 1): a randomised, double-blind, placebo-controlled, phase 3 trial,” “Efficacy and safety of once-daily oral semaglutide 25 mg and 50 mg compared with 14 mg in adults with type 2 diabetes (PIONEER PLUS): a multicentre, randomised, phase 3b trial,” “Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study.”

American Diabetes Association: “Late Breaking Weight Loss Innovations: New Drug Therapies Shown to Offer Positive Outcomes for Obesity and Type 2 Diabetes Management.”

The New England Journal of Medicine: “Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity.”

Reuters: “Experimental Lilly pill, Mounjaro both lead to 15% weight loss in clinical trials.”