Eli Lilly Develops New Weight-Loss Pill
Popular weight-loss and diabetes drugs are sometimes in short supply due to high demand. However, another option may soon become available to address the shortage.
Eli Lilly and Company recently announced that it has developed orforglipron, a pill to lower blood sugar levels and help with weight loss in people with type 2 diabetes.
Orforglipron is a glucagon-like peptide-1 (GLP-1) receptor agonist, and is in the same class of medications as the blockbuster diabetes and weight-loss drugs Ozempic, Wegovy, and Mounjaro. A GLP-1 receptor agonist is a medication that mimics the way a natural hormone called glucagon-like peptide one works in the body, according to the Mayo Clinic. GLP-1 plays a vital role in regulating blood sugar and appetite.
Wegovy is approved by the U.S. Food and Drug Administration (FDA) for weight loss in people who are obese or who are overweight and have weight-related health conditions. Ozempic and Mounjaro are approved for treating type 2 diabetes, but are used off-label for weight loss management. Eli Lilly also manufactures Mounjaro, which is approved for managing type 2 diabetes in adults, and Zepbound, which is approved for chronic weight management in adults with obesity.
Patients must inject Ozempic, Wegovy, Mounjaro, and Zepbound once a week, but Orforglipron can be taken orally once a week. Eli Lilly said in a news release that Orforglipron is the first oral small-molecule GLP-1, taken without food and water restrictions, to successfully complete a Phase 3 trial.
Data from the Phase 3 results showed that trial participants who received the highest dose of Orforglipron lost up to 16 pounds, or nearly 8 percent of their body weight, over 40 weeks. Eli Lilly said that the participants’ weight loss had not yet plateaued by the end of the study, suggesting they may continue to lose more weight. The company also reported that trial participants’ blood sugar levels dropped dramatically.
“If a doctor tested them, they wouldn’t even know they had diabetes anymore,” Dan Skovronsky, Eli Lilly’s chief scientific officer, told NBC News.
Diabetes is a chronic condition caused by the body’s inability to make enough insulin or use insulin properly, which results in elevated blood sugar levels. Insulin is a hormone the pancreas makes that helps blood sugar, also known as glucose, enter cells for energy. When this process is disrupted, glucose accumulates in the bloodstream, which may lead to serious health complications, according to the American Diabetes Association (ADA).
A blood glucose test measures the level of sugar in the blood. A1C measures an individual’s average blood sugar levels over the past two to three months. The ADA says the goal for most adults with diabetes is an A1C of less than 7 percent.
Eli Lilly said over 65 percent of participants in the Phase 3 trial who took the highest dose of Orforglipron achieved an A1C of 6.5 percent or lower. According to the trial data, participants lowered their A1C levels by an average of 1.3 percent to 1.6 percent compared with a placebo.
Skovronsky said the company is so confident in the new pill that it is already being manufactured, even though it has not yet been approved.
“When we get FDA approval, which could be next year, we hope to be able to have an abundant supply,” Skovronsky told NBC News. “One of the advantages is that it’s easier to make in our factories, so that should mean more people should have access to it.”
Eli Lilly reported that the overall safety profile of Orforglipron was consistent with established GLP-1 medications. The data showed that some patients had gastrointestinal-related adverse effects, such as nausea, diarrhea, and vomiting. The side effects were generally mild to moderate in severity.
Medical professionals have been following the promising results of Orforglipron.
“Having a pill and taking it at your convenience, I think, can be a game-changer for some people,” Dr. Melanie Jay, an obesity medicine physician and associate professor at NYU Langone Health, told NBC News.
Dr. Jay cautions that these drugs, whether in pill form or injectable, need to be managed by a doctor. These medications, she said, are “not a silver bullet, and we are finding that in real-world practice, we still have so much to learn about how to use these.”
Dr. Christopher McGowan, a gastroenterologist who operates a weight loss clinic in Cary, North Carolina, called the trial results “very encouraging.”
The reduction in A1C “is comparable to what we see with injectable GLP-1 drugs like Ozempic, though perhaps slightly less than what’s seen with dual agonists like Mounjaro,” McGowan, who was not involved in the trial, told NBC News.
McGowan pointed out that a pill has several advantages over an injectable drug. For one, a pill is easier for the drugmaker to manufacture and distribute, and it may be less intimidating for patients.
“Some patients are hesitant to start an injectable therapy, no matter how effective it is,” McGowan said. “Having a pill as an option could reduce that barrier.”
Eli Lilly said it plans to present the Phase 3 results for Orforglipron at the ADA’s 85th Scientific Sessions in June and publish them in a peer-reviewed journal. Additionally, the company said it plans to submit Orforglipron to the FDA for approval as a weight loss treatment by the end of 2025, and seek approval as a diabetes treatment in 2026.
If approved, Orforglipron would be the second oral GLP-1 medication in the United States. The first, Rybelsus, manufactured by Novo Nordisk, is a prescription medication used to improve blood sugar in adults with type 2 diabetes, and may help with weight loss.
Source Links:
https://www.nbcnews.com/nightly-news/video/eli-lilly-develops-groundbreaking-new-weight-loss-pill-237780549872
https://www.nbcnews.com/health/health-news/lilly-says-daily-pill-can-lower-blood-sugar-weight-people-type-2-diabe-rcna201605
https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically
https://www.mayoclinic.org/diseases-conditions/type-2-diabetes/expert-answers/byetta/faq-20057955
https://diabetes.org/about-diabetes/a1c
