Latest news with #orforglipron
Yahoo
17 hours ago
- Health
- Yahoo
Lilly expects orforglipron obesity results in third quarter
By Deena Beasley (Reuters) -Eli Lilly said on Saturday its experimental pill orforglipron helped diabetics lose weight and lower their blood sugar, and the company aims to announce in the third quarter trial results for the drug in overweight and obese people without diabetes. Lilly expects to submit the non-diabetes Phase 3 data to global regulatory agencies by the end of the year, said Ken Custer, head of cardiometabolic health at the company. The U.S. Food and Drug Administration typically makes new drug approval decisions 10 months after a manufacturer's submission. Lilly said it plans to file for regulatory approvals for orforglipron as a diabetes treatment in 2026. Full results of the diabetes trial were presented at the annual meeting of the American Diabetes Association in Chicago. The Phase 3 study showed that type 2 diabetes patients taking the highest dose of daily orforglipron lost nearly 8% of their body weight over 40 weeks. That compares favorably with Novo Nordisk's injected drug Ozempic, for which trials showed that diabetic patients on the highest dose lost roughly 6% of their body weight. Lilly's pill, which can be taken without food or water, lowered blood sugar levels by an average of 1.3% to 1.6% across doses. The company said the most frequently reported side effects were gastrointestinal and similar to other GLP-1 drugs, including diarrhea and vomiting. Custer said Lilly's goal in its non-diabetes trials is to achieve weight loss consistent with GLP-1 drugs that are currently available. Ozempic was shown in trials to lead to weight loss of 15% for people without diabetes over 68 weeks. He said orforglipron, which has a simpler production process than injected GLP-1 drugs such as Ozempic or Lilly's Zepbound and does not require cold storage, could mean wider global access to weight-loss drugs. "This is the type of molecule that is going to allow us to reach the broader globe," Custer said. The executive declined to comment on pricing plans for orforglipron. (Reporting By Deena BeasleyEditing by Rod Nickel)
Reuters
17 hours ago
- Health
- Reuters
Lilly expects orforglipron obesity results in third quarter
June 21 (Reuters) - Eli Lilly (LLY.N), opens new tab said on Saturday its experimental pill orforglipron helped diabetics lose weight and lower their blood sugar, and the company aims to announce in the third quarter trial results for the drug in overweight and obese people without diabetes. Lilly expects to submit the non-diabetes Phase 3 data to global regulatory agencies by the end of the year, said Ken Custer, head of cardiometabolic health at the company. The U.S. Food and Drug Administration typically makes new drug approval decisions 10 months after a manufacturer's submission. Lilly said it plans to file for regulatory approvals for orforglipron as a diabetes treatment in 2026. Full results of the diabetes trial were presented at the annual meeting of the American Diabetes Association in Chicago. The Phase 3 study showed that type 2 diabetes patients taking the highest dose of daily orforglipron lost nearly 8% of their body weight over 40 weeks. That compares favorably with Novo Nordisk's ( opens new tab injected drug Ozempic, for which trials showed that diabetic patients on the highest dose lost roughly 6% of their body weight. Lilly's pill, which can be taken without food or water, lowered blood sugar levels by an average of 1.3% to 1.6% across doses. The company said the most frequently reported side effects were gastrointestinal and similar to other GLP-1 drugs, including diarrhea and vomiting. Custer said Lilly's goal in its non-diabetes trials is to achieve weight loss consistent with GLP-1 drugs that are currently available. Ozempic was shown in trials to lead to weight loss of 15% for people without diabetes over 68 weeks. He said orforglipron, which has a simpler production process than injected GLP-1 drugs such as Ozempic or Lilly's Zepbound and does not require cold storage, could mean wider global access to weight-loss drugs. "This is the type of molecule that is going to allow us to reach the broader globe," Custer said. The executive declined to comment on pricing plans for orforglipron.
Yahoo
17 hours ago
- Health
- Yahoo
Lilly expects orforglipron obesity results in third quarter
By Deena Beasley (Reuters) -Eli Lilly said on Saturday its experimental pill orforglipron helped diabetics lose weight and lower their blood sugar, and the company aims to announce in the third quarter trial results for the drug in overweight and obese people without diabetes. Lilly expects to submit the non-diabetes Phase 3 data to global regulatory agencies by the end of the year, said Ken Custer, head of cardiometabolic health at the company. The U.S. Food and Drug Administration typically makes new drug approval decisions 10 months after a manufacturer's submission. Lilly said it plans to file for regulatory approvals for orforglipron as a diabetes treatment in 2026. Full results of the diabetes trial were presented at the annual meeting of the American Diabetes Association in Chicago. The Phase 3 study showed that type 2 diabetes patients taking the highest dose of daily orforglipron lost nearly 8% of their body weight over 40 weeks. That compares favorably with Novo Nordisk's injected drug Ozempic, for which trials showed that diabetic patients on the highest dose lost roughly 6% of their body weight. Lilly's pill, which can be taken without food or water, lowered blood sugar levels by an average of 1.3% to 1.6% across doses. The company said the most frequently reported side effects were gastrointestinal and similar to other GLP-1 drugs, including diarrhea and vomiting. Custer said Lilly's goal in its non-diabetes trials is to achieve weight loss consistent with GLP-1 drugs that are currently available. Ozempic was shown in trials to lead to weight loss of 15% for people without diabetes over 68 weeks. He said orforglipron, which has a simpler production process than injected GLP-1 drugs such as Ozempic or Lilly's Zepbound and does not require cold storage, could mean wider global access to weight-loss drugs. "This is the type of molecule that is going to allow us to reach the broader globe," Custer said. The executive declined to comment on pricing plans for orforglipron. (Reporting By Deena BeasleyEditing by Rod Nickel)
WIRED
17 hours ago
- Health
- WIRED
Eli Lilly's Obesity Pill Appears to Work as Well as Injected GLP-1s
Jun 21, 2025 9:01 AM New data from a Phase 3 trial show that the daily anti-obesity pill may be as safe and effective as drugs like Mounjaro and Ozempic for weight loss and lowering blood sugar. PHOTO-ILLUSTRATION: WIRED STAFF; GETTY IMAGES Eli Lilly's daily anti-obesity pill orforglipron appears to be as good at spurring weight loss and lowering blood sugar in diabetes patients as popular injectable GLP-1 drugs like Ozempic, according to new data from a Phase 3 trial. The results were announced today at the annual meeting of the American Diabetes Association. Eli Lilly is the maker of the blockbuster GLP-1 drug tirzepatide, approved as Mounjaro for type 2 diabetes and Zepbound for chronic weight management and obstructive sleep apnea. Like Novo Nordisk's Ozempic and Wegovy, both of Eli Lilly's tirzepatide drugs are injected on a weekly basis. But some patients have a fear of needles or would prefer to take a pill out of convenience. 'What we see is that the efficacy, safety, and tolerability are really consistent with the very best injectable GLP-1s,' says Kenneth Custer, president of cariometabolic health at Eli Lilly, of the company's experimental pill. 'We think this is a big deal.' The company plans to seek regulatory approval for orforglipron for weight management by the end of this year and for the treatment of type 2 diabetes in 2026. The 40-week trial tested three doses of orforglipron—3 milligrams, 12 milligrams, and 36 milligrams—against a placebo in 559 patients with type 2 diabetes. All three doses were effective at lowering blood sugar, while the middle and highest doses showed clinically meaningful and statistically significant reductions in body weight. The highest dose of orforglipron led to an average weight loss of 7.9 percent, or 16 pounds—comparable to the amount of weight loss seen over the same period in trials of semaglutide and tirzepatide. Eli Lilly is studying the pill in a longer study in people who are overweight or have obesity to see if the weight loss continues. In the current trial, participants took the pill once a day with no food or water restrictions. Those who were randomly assigned to orforglipron started the study at a dose of 1 milligram a day and slowly increased the dose at four-week intervals. Current GLP-1 drugs are gradually stepped up in dose as well to minimize potential side effects. Orforglipron showed similar gastrointestinal side effects as other GLP-1 drugs, with the most common being diarrhea, nausea, indigestion, and constipation. Between 4 and 8 percent of participants across the different dosing groups dropped out because of side effects, while 1 percent in the placebo group discontinued the study. An oral version of semaglutide, sold under the brand name Rybelsus, has been on the market since 2019 but is not approved for weight management and isn't as effective for weight loss as injectable GLP-1s. A pill specifically for obesity would give patients more treatment options and potentially make these drugs more accessible. Pills are typically less expensive to manufacture, and they can be mass-produced more easily, making them less prone to shortage. (Injected GLP-1 drugs were in shortage until recently.) Pills can also be transported more readily. Current GLP-1 injector pens need to be shipped and stored in a refrigerator to maintain their potency. A GLP-1 pill wouldn't need sophisticated cold-chain distribution and storage, meaning it could be sold in countries that don't have that infrastructure. 'With orforglipron offering additional advantages such as the elimination of strict pre-dosing requirements, potential lower cost, and easier storage, it will be important to see whether these features lead to even greater adherence,' says Priya Jaisinghani, a diabetes and obesity medicine specialist at NYU Langone. 'Like most chronic therapies, GLP-1s are most effective when used consistently, so a formulation that encourages long-term use could have a meaningful impact on patient outcomes.'
New York Times
17 hours ago
- Health
- New York Times
New Data Shows Just How Powerful the Next Weight-Loss Drugs May Be
Doctors call the new weight-loss drugs revolutionary. Game-changing. Unprecedented. Soon, they may also call them obsolete. Drugmakers are racing to develop the next wave of obesity and diabetes medications that they hope will be even more powerful than those currently on the market. 'I think what we are going to see very quickly is that Wegovy has received a lot of the press attention, because it got there first,' said Simon Cork, a senior lecturer at Anglia Ruskin University in England who has studied obesity. 'But it will be rapidly overtaken by much more potent medications.' On Saturday, researchers presented data at an annual meeting of the American Diabetes Association on perhaps the most anticipated of these medications: a daily pill. A late-stage study showed that the drug, called orforglipron, appeared to be about as effective as a weekly Ozempic injection at inducing weight loss and lowering blood sugar. It is just one of over a dozen experimental medications that researchers will share data about at the conference this weekend. Some of these drugs are still in early trials, but others could hit the market as soon as next year. They include medications that may lead to more weight loss than the roughly 15 to 20 percent body weight people lose on existing drugs. They may also be easier to take than weekly injections and help people shed pounds without dropping as much muscle. More competition — and, in the case of the pill, lower manufacturing costs — might also mean that, eventually, patients pay less. 'A lot of people are like, 'Oh, we have Ozempic, everything's good now,'' said Megan Capozzi, a research assistant professor at the University of Washington Medicine who studies treatments for diabetes and obesity. 'But I think there are so many more things to improve on.' Want all of The Times? Subscribe.
