That means it could lead to more weight loss than current medications like Ozempic, Wegovy, and Mounjaro, comparable to bariatric surgery. While GLP-1 drugs have paved the way for a new era of healthcare, they have some drawbacks. They need to be injected (a draw-back for some patients), that injection must be administered once a week for effects to last, and manufacturers struggled to keep up with demand. Almost 7% of study participants permanently stopped taking the pill because of adverse effects, compared to almost 6% with a placebo.
Improving metabolic conditions
In April, the pharmaceutical company Pfizer announced it would stop developing danuglipron, making it the second medication the company has discontinued because of potentially dangerous liver side effects. Those drugs have different molecular structures than orforglipron, Wharton says, which could explain why orforglipron didn’t cause the same trouble. Two new medications taken by mouth can help trim body weight in people living with obesity, scientists report in two studies published September 16 and 17 in the New England Journal of Medicine.
- “The race is definitely on to get one of these pills to the finish line,” NBC medical contributor Dr. Natalie Azar said on TODAY.
- Researchers are also exploring the benefits of combining GLP-1 receptor agonists with other therapeutic agents.
- In the highest-dose group, about 60 percent of participants lost at least 10 percent of their body weight, while 40 percent lost 15 percent or more.
- These observations are consistent with a peripheral mechanism, possibly involving delayed gastric emptying, that may blunt alcohol’s immediate effects.
- People should take the Wegovy pill in the morning after fasting overnight and with no more than 4 ounces of water.
A large portion of the data presented comes from animal studies or early-stage human trials. However, some presentations include mid-to late-stage trials, according to a list shared by the organization. The drugmaker Lilly announced topline results of a clinical new ozempic experimental glp-1 drug trial of a new pill in the same drug class as injectables like Ozempic. The study experiment comprised a single session at a controlled “Research Bar” wherein each participant was provided a carefully calculated dose of alcohol designed to achieve a target blood alcohol level. Over the following 60 minutes, the research team repeatedly measured participants’ breath alcohol concentration (BrAC) with a breathalyzer and asked them to rate their perceived level of intoxication on a simple scale.
“With these positive data in hand, we are now planning to submit orforglipron for regulatory review by year-end and are prepared for a global launch to address this urgent public health need,” he added. Eli Lilly has also started manufacturing and stockpiling its GLP-1 pills so they’re ready to hit the market once approval comes, NBC’s Stephanie Gosk previously reported. The results of the phase 3 trial were published on Wednesday, Sept. 17 in The New England Journal of Medicine. He covers the Food and Drug Administration, with a special focus on Covid vaccines, prescription drug pricing and health care. On Saturday, there were also new findings on the experimental mazdutide, which Lilly has given permission to biotech firm Innovent Biologics to develop in China.
What Is GLP-1 Microdosing and Does It Lead to Weight Loss? Doctors Explain
In a phase 2 trial of people who were overweight or had obesity, Boehringer Ingelheim’s survodutide, which uses both GLP-1 and glucagon, led to weight loss of 19% at 46 weeks. Another phase 2 study in people with MASH and fibrosis found that 83% of participants also showed improvement in MASH. Wharton hopes both oral drugs will be available to consumers by 2026, though that depends how quickly they move through the FDA’s approval process. Right now, many people, especially those from marginalized populations, can’t access GLP-1 medications, for financial or other reasons. These results strongly support the need for larger, randomized clinical trials to confirm these effects and explore the potential of repurposing GLP-1 RAs as a novel treatment for reducing harmful alcohol consumption. This present study provides preliminary evidence consistent with the idea that GLP-1 RAs alter the body’s response to alcohol through a potentially peripheral mechanism.
Eli Lilly is racing to get the first weight-loss pill on the market
The pill’s safety and tolerability was similar to the injectable version of Wegovy, Novo Nordisk said. “The race is definitely on to get one of these pills to the finish line,” NBC medical contributor Dr. Natalie Azar said on TODAY. Some of the drugs showcased could be available for prescription in the U.S. within the next few years. Drug companies are racing to develop GLP-1 drugs following the blockbuster success of Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro and Zepbound. Nicoletta Lanese is the health channel editor at Live Science and was previously a news editor and staff writer at the site.
Ozempic in a pill? New oral drug may work as well as Ozempic-style injectables
Drugs like Ozempic and Wegovy have completely transformed how we manage both diabetes and obesity. With plenty of clinical research and real-world success stories, these medications are bringing hope to millions who are struggling with obesity. On Sunday, Lilly released new data about retatrutide, an injectable drug that combines GLP-1 and glucagon, plus another hormone called GIP. In a statement published Thursday (April 17), Lilly shared the topline results of a late-stage trial of orforglipron. However, as of yet, GLP-1s are all injectable medications that require refrigeration, The New York Times reported.
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An Eli Lilly employee collects product during the manufacturing of orforglipron, an investigational oral GLP-1 drug, at a Lilly facility. New clinical trials show that orforglipron and another oral drug help people with obesity lose weight. The study used data from 20 adult (21+ years) participants (July 2023 to May 2024), half of whom were administered a maintenance dose (minimum 4 weeks) of GLP-1 RAs (cases). Because this was not a randomized trial, the study compared participants already taking GLP-1 RAs with matched controls not using these drugs. The first GLP-1 receptor agonist to receive FDA approval was exenatide, marketed as Byetta, in 2005. Derived from the saliva of the Gila monster, a lizard native to the southwestern United States, exenatide mimicked the effects of human GLP-1.
- A large portion of the data presented comes from animal studies or early-stage human trials.
- Those side effects led to more than 20 percent of participants in each dosage group dropping out during the course of the study.
- The other trial tested orforglipron, a different oral GLP-1 made by the pharmaceutical company Eli Lilly.
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While the existing drugs are highly effective, new drugs that are more affordable and have fewer side effects are needed, McGowan added. “Given that participants had not yet reached a weight plateau at the time the study ended, it appears that full weight reduction was not yet attained,” the Lilly statement noted. “Thankfully, it looks very safe,” Drucker says, but scientists still need to do longer-term studies in larger groups of people.
Your trusted guide to the latest breakthroughs, market trends, and regulations in pharma & biotech. Novo Nordisk says it has already begun production so there’s an “ample supply” on hand when the Wegovy pill is approved. People should take the Wegovy pill in the morning after fasting overnight and with no more than 4 ounces of water. The reason for the difference is that there’s “variable absorption” when medicines are taken by mouth rather than injected since “the gut is different in different people,” Azar noted.
The FDA approved Rybelsus, an oral version of semaglutide manufactured by the drug company Novo Nordisk, in 2019. In one of the new clinical trials, Wharton and other researchers tested a higher-dose version of the drug, 25 milligrams rather than 14 milligrams, which is the highest dose Rybelsus comes in. The trial followed more than 300 participants for up to 64 weeks, and Wharton’s team saw, on average, a nearly 14 percent drop in body weight among people taking the drug. The introduction of GLP-1 receptor agonists, from exenatide to semaglutide, has transformed the landscape of diabetes and obesity treatment. These drugs offer potent glucose-lowering effects, significant weight loss benefits, and the potential to address a range of metabolic conditions. As research continues, the future of GLP-1 receptor agonists looks promising, with new formulations, expanded indications, and innovative combination therapies on the horizon.
Eli Lilly says it plans to submit orforglipron for regulatory review by the end of the year. Eli Lilly says more detailed results will be presented in September at the European Association for the Study of Diabetes annual meeting and published in a peer-reviewed journal. In an earlier trial, retatrutide helped people lose, on average, about 24% of their body weight, the equivalent of about 58 pounds — greater weight loss than any other drug on the market. Dr. Scott Harris, Altimmune’s chief medical officer, said the drug has been shown to help people lose weight, as well as provide health benefits to the liver and heart. Some studies have suggested that semaglutide, the active ingredient in Ozempic and Wegovy, can cause muscle loss. Trial participants on the highest dose lost an average of 27.3 lb (12.4%) at 72 weeks, and 59.6% of participants on this dose lost at least 10% of their body weight.
“Longer-acting versions of GLP-1 medications offer the potential for greater convenience and potentially improved adherence and sustained use over time,” McGowan said. This combination is expected to help people lose significantly more weight than semaglutide alone, Novo Nordisk says. However, as we reported late last year, the oral medications are expected to be cheaper than existing injectables, but exactly how much consumers will be expected to pay is yet to be confirmed. The side effects were similar to the injectable version of Wegovy and were “generally mild to moderate in severity,” the company said.
Studies suggest that, by slowing gastric emptying, these drugs appear to delay alcohol’s absorption into the bloodstream, which in turn blunts the initial physiological and psychological “buzz”. It hasn’t been directly tested against other medications but the results are comparable to what we’ve seen in trials of semaglutide (Ozempic, Wegovy) after 68 weeks. It’s also a big win for Lilly, which has pulled ahead of rival Novo Nordisk in getting the first small molecule oral GLP-1 drug to market. Nonetheless, it wasn’t enough to stop the company’s shares taking a tumble, with earlier estimates predicting that orforglipron would deliver around 15% weight loss. Participants who received orforglipron started the study at a dose of 1 milligram daily and then increased the dose every four weeks to their final maintenance dose.
