Latest news with #DanSkovronsky
Express Tribune
17-04-2025
- Health
- Express Tribune
Lilly's oral weight-loss pill shows promise amid pharma shakeup: TIME
Listen to article In a detailed feature by TIME Magazine, pharmaceutical giant Eli Lilly has unveiled promising early results from clinical trials of its experimental oral drug orforglipron, a GLP-1-based treatment for diabetes and weight loss. The development marks a potentially transformative moment for both the company and the obesity-treatment landscape. The data, presented during a critical meeting at Lilly's Indianapolis headquarters on April 15, showed that orforglipron lowered blood sugar levels and aided weight loss without serious side effects like liver toxicity—an issue that recently led Pfizer to abandon its own oral drug in the same category. Orforglipron's results were comparable to Lilly's injectable blockbuster tirzepatide (Mounjaro). If approved by the FDA, orforglipron could become the first oral GLP-1 drug for weight loss on the market. Unlike competing drugs, it requires no dietary restrictions or timing constraints and is easier and cheaper to manufacture and distribute—especially in areas where injectables are impractical. Lilly's CEO David Ricks and Chief Scientific Officer Dr Dan Skovronsky credited the company's agile approach, culture shift, and high-speed innovation for the drug's progress. The pill was licensed from Japan's Chugai in 2018 and developed 30–40% faster than industry averages, according to Ricks. The company is investing heavily in domestic production, anticipating a surge in demand. Trials are ongoing to evaluate orforglipron's effectiveness in non-diabetic obesity and other conditions like hypertension. If successful, the drug could dramatically expand access to obesity treatments and redefine the market. This effort is part of Lilly's broader push to break industry norms, including direct-to-consumer models like Lilly Direct, which bypass intermediaries to lower costs. With additional breakthroughs like the Alzheimer's drug Kisunla, Lilly is now the world's most valuable pharma firm—and possibly the first on track to a $1 trillion valuation.
CNN
17-04-2025
- Health
- CNN
Eli Lilly says experimental GLP-1 pill helped people with diabetes lose weight and lower blood sugar
Drugmaker Eli Lilly said Thursday that an experimental pill form of popular GLP-1 medications helped people with type 2 diabetes lose an average of nearly 8% of their body weight after 40 weeks and lowered their A1C levels. Lilly, which makes the injectable drugs Zepbound to treat obesity and Mounjaro and Trulicity to treat diabetes, is among several companies chasing an effective pill form of GLP-1s. The only such pill available so far comes with strict diet restrictions. Lilly's announcement comes on the heels of an announcement from Pfizer, which said Monday that it was ending development of its daily pill treatment for obesity. A patient in the clinical trial had a possible liver injury that was no longer a problem once they stopped taking that drug, Pfizer said. In 2020, the US Food and Drug Administration approved Novo Nordisk's Rybelsus for treatment of type 2 diabetes, but it has to be taken on an empty stomach. Some doctors also report that Rybelsus may not be as effective as injections yet still comes with side effects. Lilly says that no such diet restrictions are needed with its experimental oral medication, orforglipron, and that it's the first drug of its kind to complete a Phase 3 trial. the Indianapolis company said that in a study of more than 550 people, orforglipron reduced weight by an average of 16 pounds (7.9%) among people who had type 2 diabetes with inadequate glycemic control with diet and exercise alone, and who were using the highest dose of the medication. The participants were still losing weight by the end of the 40-week trial. The trial also achieved its primary goal of lowering participants' A1C level – a measurement of the average amount of glucose in blood over the previous three months – more than a placebo. Participants saw an average reduction of 1.3% to 1.6% from a baseline of 8%. Glucose, or blood sugar, is the body's main source of energy. People who have diabetes can't make enough insulin, a hormone the pancreas makes to help the body keep blood sugar levels in a certain range. People with type 2 diabetes may also have cells that are resistant to the effects of insulin. GLP-1 drugs help control blood sugar by stimulating the pancreas to release insulin and suppressing the release of another hormone. GLP-1s also help reduce the feeling of hunger and can make people feel full for longer. Orforglipron helped more than 65% of trial participants get to or maintain their A1C at or under 6.5%, the level at which people are considered to have diabetes, Lilly said. Dr. Dan Skovronsky, Lilly's chief scientific officer, said Wednesday that even before the trial results were released within the company, he knew they would be good. 'When I walked into the room to see the results, I saw everybody smiling, so I knew they were about to share good news with me,' he said. Liver injury like what was seen in the trial of the Pfizer drug is always possible with small-molecule drugs like this one, Skovronsky said, and it is difficult to detect whether it will cause a problem until the drug is tested in enough people. 'We did not see a liver safety signal with ours, which was a relief,' Skovronsky said. Side effects with the pill were similar to those reported with injectable forms of GLP-1 drugs. The adverse events were considered generally mild to moderate, according to the company, with upset stomach the most commonly reported. Many people who use injectable GLP-1s eventually quit because of side effects. But by the end of this trial, Skovronsky said, more than 90% of the participants had stuck with the medication. GLP-1 injections are highly effective, but for many people, they are cost-prohibitive. The injections are also complicated and costly to make. A daily pill would be easier to use and, because it would be cheaper to manufacture, could possibly lower patient costs, expert say. It's too early to know how much orforglipron might cost if it's approved. Injection drugs have other downsides, as well. They need to be refrigerated and require plastic applications, whereas pills have less packaging. 'Drugs in tablet form are valuable for a lot of patients for a lot of reasons, particularly those who are needle-phobic,' said Dr. Amy Rothberg, a clinical professor of medicine in the Division of Metabolism, Endocrinology & Diabetes in the Department of Internal Medicine and a research professor of nutritional sciences in the School of Public Health at the University of Michigan. 'And it probably just simplifies things to just add on another pill, as opposed to taking a shot, which is a little more complex.' Rothberg, who was not involved with the new trial, hopes Lilly will pass on cost savings to patients if the drug is approved. 'We could reach many more people then,' she said. A growing number of people do need treatment for diabetes or obesity. More than 40% of US adults live with obesity, and about 11.6% of the population – an estimated 38.4 million Americans – had been diagnosed with diabetes as of 2021, according to the US Centers for Disease Control and Prevention. Most have type 2 diabetes. Skovronsky said that Lilly has already been producing orforglipron pills after getting earlier promising results assuming that the rest of the trials will go well. 'That way, we'll have adequate supply to meet demand,' he said. Lilly plans to publish the results of its late-stage trial in a peer-reviewed journal and expects to share more results later this year, along with findings from another clinical trial program that it created to evaluate the drug for its weight management qualities. It's also testing to see if a pill might improve people's high blood pressure and sleep apnea, two conditions that have been helped with certain injectable GLP-1s. Lilly said it expects to apply for approval of orforglipron for weight management by the end of the year and submit results concerning its treatment of type 2 diabetes in 2026.
Yahoo
17-04-2025
- Health
- Yahoo
Lilly says daily pill can lower blood sugar and weight in people with Type 2 diabetes
A daily pill from Eli Lilly lowered blood sugar levels and induced weight loss in people with Type 2 diabetes, the company announced Thursday. The experimental pill, called orforglipron, is a GLP-1 drug — the same class of medicine as the blockbuster diabetes and weight loss drugs Ozempic, Wegovy and Mounjaro. Orforglipron is taken orally, however, not as a weekly injection. 'Everybody knows GLP-1s now, and they're sort of famous as injectable peptide drugs, but we've engineered this now into a new kind of molecule that can be taken as a pill form,' Dr. Dan Skovronsky, Lilly's chief scientific officer, said in an interview. If it is approved, Lilly's drug would be the second oral GLP-1 drug available in the United States. The first, Rybelsus, made by Novo Nordisk, contains semaglutide, the active ingredient in Ozempic and Wegovy. Rybelsus is approved for Type 2 diabetes. Lilly said in a news release that in a phase 3 clinical trial, orforglipron lowered A1C levels by 1.6% after 40 weeks compared with a placebo. The full results of the trial were not available to review. A1C is a measure of a person's average blood sugar levels over the previous two to three months, according to the American Diabetes Association. An A1C below 5.7% is considered normal; a result of 6.5% or above is in the range for diabetes. Results that fall between those values are in the prediabetes range. More than 65% of the participants taking orforglipron had A1C readings equal to or less than 6.5% after 40 weeks. Participants who received the highest dose of the drug lost up to 16 pounds, or 7.9% of their body weight, over the study period. Lilly said the results of the clinical trial will be published in a peer-reviewed journal and presented at the American Diabetes Association conference in June. Dr. Christopher McGowan, a gastroenterologist who runs a weight loss clinic in Cary, North Carolina, called Lilly's 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,' said McGowan, who was not involved in the trial. A pill, McGowan added, has several advantages over an injectable drug. For the drugmaker, it is easier to manufacture and distribute. For some patients, it may be less intimidating. 'Some patients are hesitant to start an injectable therapy, no matter how effective it is,' he said. 'Having a pill as an option could reduce that barrier.' Lilly is also researching how well orforglipron works for weight loss alone in people without Type 2 diabetes. In phase 2 clinical trial — the findings of which were published in 2023 in the New England Journal of Medicine — daily orforglipron was found to reduce body weight by an average of 9.4% to 14.7% after 36 weeks, depending on the dose. Dr. Susan Spratt, an endocrinologist and senior medical director at Duke Health who was not involved in the trial, questioned whether orforglipron had any drug-drug interactions — as is the case, she said, with Rybelsus, which can interact with certain thyroid medications. Lilly said Thursday that phase 3 results from the weight loss trial will be available later this year. It plans to submit the drug to the Food and Drug Administration as a weight loss treatment by the end of 2025. In 2026, it plans to apply for approval as a diabetes treatment. This article was originally published on
Yahoo
17-04-2025
- Health
- Yahoo
Experimental GLP-1 pill helped people with diabetes lose weight and lower blood sugar, Eli Lilly says
Drugmaker Eli Lilly said Thursday that an experimental pill form of popular GLP-1 medications helped people with type 2 diabetes lose an average of nearly 8% of their body weight after 40 weeks and lowered their A1C levels. Lilly, which makes the injectable drugs Zepbound to treat obesity and Mounjaro and Trulicity to treat diabetes, is among several companies chasing an effective pill form of GLP-1s. The only such pill available so far comes with strict diet restrictions. Lilly's announcement comes on the heels of an announcement from Pfizer, which said Monday that it was ending development of its daily pill treatment for obesity. A patient in the clinical trial had a possible liver injury that was no longer a problem once they stopped taking that drug, Pfizer said. In 2020, the US Food and Drug Administration approved Novo Nordisk's Rybelsus for treatment of type 2 diabetes, but it has to be taken on an empty stomach. Some doctors also report that Rybelsus may not be as effective as injections yet still comes with side effects. Lilly says that no such diet restrictions are needed with its experimental oral medication, orforglipron, and that it's the first drug of its kind to complete a Phase 3 trial. the Indianapolis company said that in a study of more than 550 people, orforglipron reduced weight by an average of 16 pounds (7.9%) among people who had type 2 diabetes with inadequate glycemic control with diet and exercise alone, and who were using the highest dose of the medication. The participants were still losing weight by the end of the 40-week trial. The trial also achieved its primary goal of lowering participants' A1C level – a measurement of the average amount of glucose in blood over the previous three months – more than a placebo. Participants saw an average reduction of 1.3% to 1.6% from a baseline of 8%. Glucose, or blood sugar, is the body's main source of energy. People who have diabetes can't make enough insulin, a hormone the pancreas makes to help the body keep blood sugar levels in a certain range. People with type 2 diabetes may also have cells that are resistant to the effects of insulin. GLP-1 drugs help control blood sugar by stimulating the pancreas to release insulin and suppressing the release of another hormone. GLP-1s also help reduce the feeling of hunger and can make people feel full for longer. Orforglipron helped more than 65% of trial participants get to or maintain their A1C at or under 6.5%, the level at which people are considered to have diabetes, Lilly said. Dr. Dan Skovronsky, Lilly's chief scientific officer, said Wednesday that even before the trial results were released within the company, he knew they would be good. 'When I walked into the room to see the results, I saw everybody smiling, so I knew they were about to share good news with me,' he said. Liver injury like what was seen in the trial of the Pfizer drug is always possible with small-molecule drugs like this one, Skovronsky said, and it is difficult to detect whether it will cause a problem until the drug is tested in enough people. 'We did not see a liver safety signal with ours, which was a relief,' Skovronsky said. Side effects with the pill were similar to those reported with injectable forms of GLP-1 drugs. The adverse events were considered generally mild to moderate, according to the company, with upset stomach the most commonly reported. Many people who use injectable GLP-1s eventually quit because of side effects. But by the end of this trial, Skovronsky said, more than 90% of the participants had stuck with the medication. GLP-1 injections are highly effective, but for many people, they are cost-prohibitive. The injections are also complicated and costly to make. A daily pill would be easier to use and, because it would be cheaper to manufacture, could possibly lower patient costs, expert say. It's too early to know how much orforglipron might cost if it's approved. Injection drugs have other downsides, as well. They need to be refrigerated and require plastic applications, whereas pills have less packaging. 'Drugs in tablet form are valuable for a lot of patients for a lot of reasons, particularly those who are needle-phobic,' said Dr. Amy Rothberg, a clinical professor of medicine in the Division of Metabolism, Endocrinology & Diabetes in the Department of Internal Medicine and a research professor of nutritional sciences in the School of Public Health at the University of Michigan. 'And it probably just simplifies things to just add on another pill, as opposed to taking a shot, which is a little more complex.' Rothberg, who was not involved with the new trial, hopes Lilly will pass on cost savings to patients if the drug is approved. 'We could reach many more people then,' she said. A growing number of people do need treatment for diabetes or obesity. More than 40% of US adults live with obesity, and about 11.6% of the population – an estimated 38.4 million Americans – had been diagnosed with diabetes as of 2021, according to the US Centers for Disease Control and Prevention. Most have type 2 diabetes. Skovronsky said that Lilly has already been producing orforglipron pills after getting earlier promising results assuming that the rest of the trials will go well. 'That way, we'll have adequate supply to meet demand,' he said. Lilly plans to publish the results of its late-stage trial in a peer-reviewed journal and expects to share more results later this year, along with findings from another clinical trial program that it created to evaluate the drug for its weight management qualities. It's also testing to see if a pill might improve people's high blood pressure and sleep apnea, two conditions that have been helped with certain injectable GLP-1s. Lilly said it expects to apply for approval of orforglipron for weight management by the end of the year and submit results concerning its treatment of type 2 diabetes in 2026.
CNN
17-04-2025
- Health
- CNN
Experimental GLP-1 pill helped people with diabetes lose weight and lower blood sugar, Eli Lilly says
Drugmaker Eli Lilly said Thursday that an experimental pill form of popular GLP-1 medications helped people with type 2 diabetes lose an average of nearly 8% of their body weight after 40 weeks and lowered their A1C levels. Lilly, which makes the injectable drugs Zepbound to treat obesity and Mounjaro and Trulicity to treat diabetes, is among several companies chasing an effective pill form of GLP-1s. The only such pill available so far comes with strict diet restrictions. Lilly's announcement comes on the heels of an announcement from Pfizer, which said Monday that it was ending development of its daily pill treatment for obesity. A patient in the clinical trial had a possible liver injury that was no longer a problem once they stopped taking that drug, Pfizer said. In 2020, the US Food and Drug Administration approved Novo Nordisk's Rybelsus for treatment of type 2 diabetes, but it has to be taken on an empty stomach. Some doctors also report that Rybelsus may not be as effective as injections yet still comes with side effects. Lilly says that no such diet restrictions are needed with its experimental oral medication, orforglipron, and that it's the first drug of its kind to complete a Phase 3 trial. the Indianapolis company said that in a study of more than 550 people, orforglipron reduced weight by an average of 16 pounds (7.9%) among people who had type 2 diabetes with inadequate glycemic control with diet and exercise alone, and who were using the highest dose of the medication. The participants were still losing weight by the end of the 40-week trial. The trial also achieved its primary goal of lowering participants' A1C level – a measurement of the average amount of glucose in blood over the previous three months – more than a placebo. Participants saw an average reduction of 1.3% to 1.6% from a baseline of 8%. Glucose, or blood sugar, is the body's main source of energy. People who have diabetes can't make enough insulin, a hormone the pancreas makes to help the body keep blood sugar levels in a certain range. People with type 2 diabetes may also have cells that are resistant to the effects of insulin. GLP-1 drugs help control blood sugar by stimulating the pancreas to release insulin and suppressing the release of another hormone. GLP-1s also help reduce the feeling of hunger and can make people feel full for longer. Orforglipron helped more than 65% of trial participants get to or maintain their A1C at or under 6.5%, the level at which people are considered to have diabetes, Lilly said. Dr. Dan Skovronsky, Lilly's chief scientific officer, said Wednesday that even before the trial results were released within the company, he knew they would be good. 'When I walked into the room to see the results, I saw everybody smiling, so I knew they were about to share good news with me,' he said. Liver injury like what was seen in the trial of the Pfizer drug is always possible with small-molecule drugs like this one, Skovronsky said, and it is difficult to detect whether it will cause a problem until the drug is tested in enough people. 'We did not see a liver safety signal with ours, which was a relief,' Skovronsky said. Side effects with the pill were similar to those reported with injectable forms of GLP-1 drugs. The adverse events were considered generally mild to moderate, according to the company, with upset stomach the most commonly reported. Many people who use injectable GLP-1s eventually quit because of side effects. But by the end of this trial, Skovronsky said, more than 90% of the participants had stuck with the medication. GLP-1 injections are highly effective, but for many people, they are cost-prohibitive. The injections are also complicated and costly to make. A daily pill would be easier to use and, because it would be cheaper to manufacture, could possibly lower patient costs, expert say. It's too early to know how much orforglipron might cost if it's approved. Injection drugs have other downsides, as well. They need to be refrigerated and require plastic applications, whereas pills have less packaging. 'Drugs in tablet form are valuable for a lot of patients for a lot of reasons, particularly those who are needle-phobic,' said Dr. Amy Rothberg, a clinical professor of medicine in the Division of Metabolism, Endocrinology & Diabetes in the Department of Internal Medicine and a research professor of nutritional sciences in the School of Public Health at the University of Michigan. 'And it probably just simplifies things to just add on another pill, as opposed to taking a shot, which is a little more complex.' Rothberg, who was not involved with the new trial, hopes Lilly will pass on cost savings to patients if the drug is approved. 'We could reach many more people then,' she said. A growing number of people do need treatment for diabetes or obesity. More than 40% of US adults live with obesity, and about 11.6% of the population – an estimated 38.4 million Americans – had been diagnosed with diabetes as of 2021, according to the US Centers for Disease Control and Prevention. Most have type 2 diabetes. Skovronsky said that Lilly has already been producing orforglipron pills after getting earlier promising results assuming that the rest of the trials will go well. 'That way, we'll have adequate supply to meet demand,' he said. Lilly plans to publish the results of its late-stage trial in a peer-reviewed journal and expects to share more results later this year, along with findings from another clinical trial program that it created to evaluate the drug for its weight management qualities. It's also testing to see if a pill might improve people's high blood pressure and sleep apnea, two conditions that have been helped with certain injectable GLP-1s. Lilly said it expects to apply for approval of orforglipron for weight management by the end of the year and submit results concerning its treatment of type 2 diabetes in 2026.
