Latest news with #DanSkovronsky
Yahoo
5 days ago
- Health
- Yahoo
Could GPL-1 weight loss soon come in pill form? What we know
Eli Lilly, the pharmaceutical company behind GLP-1 injection Zepbound, is working to bring its weight loss drug to the market in pill form. In an Aug. 7 earnings call, Eli Lilly CEO David Ricks told investors that the company plans to submit the drug, orforglipron, to the FDA for approval by the end of the year. Dan Skovronsky, chief scientific officer and president of Lilly Immunology, said that the company was "very pleased" with the safety and efficacy of orforglipron as seen in trials so far. Unlike injectable obesity drugs, which are peptides designed to mimic the appetite-controlling GLP-1 hormone, orforglipron is a small molecule pill that is easier to manufacture and package, said Kenneth Custer, president of Lilly's cardiometabolic health division. Lilly views the once-daily pill as a promising alternative to injections that could be used for early intervention and long-term disease management, Custer said. Here's what we know so far about the proposed weight loss pill. What have the trials found? In a clinical trial, the company's weight loss pill resulted in a nearly 12% weight loss at 72 weeks for participants who took the highest dose of the medication. On average, participants lost 7.8% to 12.4% of their body weight, and 40% of people on the highest dose lost more than 15%, Eli Lilly reported. The most commonly reported side effects included gastrointestinal issues consistent with other GLP-1s, such as nausea, vomiting, and diarrhea. Five to ten percent of patients discontinued the drug across doses, the company said, which was one of two late-stage trials the drug must pass before being submitted for federal approval. While Eli Lilly saw the results as indicators of success, investors on the call expressed concerns. Some had hoped that its efficacy would more closely resemble that of existing injections on the market — which can result in up to a 20% body weight loss — while others noted the trial drop-out rate of 12% due to side effects or personal reasons. When will the weight loss pill hit the market? While there is not yet an official timeline, Eli Lilly executives have said they plan to submit orforglipron for federal approval by the end of the year. Reviews of New Drug Approval submissions to the FDA usually last one to two years before a drug is greenlit for manufacturing. Contributing: Alysa Guffey, Indianapolis Star; Reuters This article originally appeared on USA TODAY: GLP-1 weight loss could soon come in pill form: What to know Sign in to access your portfolio
USA Today
5 days ago
- Health
- USA Today
Could GPL-1 weight loss soon come in pill form? What we know
Eli Lilly, the pharmaceutical company behind GLP-1 injection Zepbound, is working to bring its weight loss drug to the market in pill form. In an Aug. 7 earnings call, Eli Lilly CEO David Ricks told investors that the company plans to submit the drug, orforglipron, to the FDA for approval by the end of the year. Dan Skovronsky, chief scientific officer and president of Lilly Immunology, said that the company was "very pleased" with the safety and efficacy of orforglipron as seen in trials so far. Unlike injectable obesity drugs, which are peptides designed to mimic the appetite-controlling GLP-1 hormone, orforglipron is a small molecule pill that is easier to manufacture and package, said Kenneth Custer, president of Lilly's cardiometabolic health division. Lilly views the once-daily pill as a promising alternative to injections that could be used for early intervention and long-term disease management, Custer said. Here's what we know so far about the proposed weight loss pill. What have the trials found? In a clinical trial, the company's weight loss pill resulted in a nearly 12% weight loss at 72 weeks for participants who took the highest dose of the medication. On average, participants lost 7.8% to 12.4% of their body weight, and 40% of people on the highest dose lost more than 15%, Eli Lilly reported. The most commonly reported side effects included gastrointestinal issues consistent with other GLP-1s, such as nausea, vomiting, and diarrhea. Five to ten percent of patients discontinued the drug across doses, the company said, which was one of two late-stage trials the drug must pass before being submitted for federal approval. While Eli Lilly saw the results as indicators of success, investors on the call expressed concerns. Some had hoped that its efficacy would more closely resemble that of existing injections on the market — which can result in up to a 20% body weight loss — while others noted the trial drop-out rate of 12% due to side effects or personal reasons. When will the weight loss pill hit the market? While there is not yet an official timeline, Eli Lilly executives have said they plan to submit orforglipron for federal approval by the end of the year. Reviews of New Drug Approval submissions to the FDA usually last one to two years before a drug is greenlit for manufacturing. Contributing: Alysa Guffey, Indianapolis Star; Reuters
Time Magazine
6 days ago
- Health
- Time Magazine
Eli Lilly Says Its New Weight-Loss Pill Is Highly Effective
In eagerly awaited results from a new study, the pharmaceutical company Eli Lilly reports that a pill its scientists developed causes people who are overweight or obese, but not diabetic, to lose significant amounts of weight. The drug, called orforglipron, differs from Lilly's injectable drug, tirzepatide (which is approved as Mounjaro to treat diabetes and as Zepbound to treat obesity and some forms of obstructive sleep apnea). While tirzepatide targets two hormones, GLP-1 and GIP, orforglipron just targets GLP-1. Lilly and other companies that make similar medicines have been racing to create oral weight-loss drugs, since weekly injections are not always appealing to patients. The trial included more than 3,100 overweight or obese adults who had an obesity-related medical problem but not diabetes. Those taking the pill daily for almost a year and a half lost 12% of their body weight on average, or 27 pounds. People taking a placebo lost just over two pounds. The findings have not yet been published in a peer-reviewed journal but will be presented in September at the annual meeting of the European Association for the Study of Diabetes. Based on the results, Lilly says it plans to file for approval of orforglipron from the U.S. Food and Drug Administration to treat obesity by the end of the year. If approved, Lilly says, it will be able to provide the pills by next year. The company is waiting for final results from a similar study of weight loss in people with diabetes; early results released in April indicate that the drug helped people with diabetes lower their blood sugar. 'The results we got were as good as we can possibly achieve with an oral small molecule GLP-1," says Dr. Dan Skovronsky, Lilly's chief scientific officer. 'The safety, tolerability, and efficacy were all in line with what we achieved with the injectable drug, yet now delivered in an easy-to-use, once-a-day pill.' Read More: The Health Risks and Benefits of Weight-Loss Drugs Among people in the study who took the drug, risk factors for heart disease such as LDL cholesterol, triglycerides, blood pressure, and a marker of inflammation also dropped, Skovronsky notes. That supports earlier data finding that GLP-1 drugs can lower the risk of heart disease as well. As with the injectable form, people taking the pills had to gradually increase their dose before reaching the maximum dose, mainly to minimize the side effects of gastrointestinal distress. In the study, people started out at 6 mg, then increased to 12 mg four weeks later, then to the maintenance dose of 36 mg four weeks after that. Orforglipron's side effect profile was similar to that of the injectable drugs, which is reassuring, says Skovronsky. 'There were two things I worried about,' he says. 'One, when you take something orally, you are exposing the stomach and intestines to a higher concentration of the drug. If that's where the side effects are caused, then [the oral] form could make them worse. But it wasn't the case at all.' It also wasn't clear what would happen if people in the study missed doses, since it's sometimes challenging to take a pill every day. Because the dose is carefully titrated up, Skovronsky said it wasn't known if people who missed pills for a few days would lose the tolerance they had built up to the side effects and have to restart their dosing schedule. 'What we found was that the side effects were similar to the injections, even though people missed the dose every once in a while,' he says. Read More: Is Ozempic the New Anti-Inflammatory Wonder Drug? Novo Nordisk, a competitor that makes Ozempic for treating diabetes and Wegovy for weight management, also has an oral form of its active ingredient, semaglutide, that is already approved to treat diabetes. The company has applied for approval to treat obesity in people without diabetes and expects a decision by the end of the year. If orforglipron is approved, it could increase access to GLP-1 medications in the U.S. and around the world. The oral drug is cheaper than the injectable, since it does not require a sterile injectable pen. Some people are also reluctant to inject themselves weekly, so taking the medication by mouth would be a welcome option. As more doctors and patients figure out the best way to use GLP-1 drugs to manage weight, a pill could either kickstart weight loss or become part of a long-term maintenance program for people who have hit their weight-loss goal. 'This can enable us to go earlier in the disease course, because people sometimes hold off on the injections until the disease—in this case, obesity—is more severe,' says Skovronsky. 'We want to treat obesity at its earliest stages, and this provides a good opportunity to do that.' Skovronsky says Lilly is also studying weight-maintenance approaches with orforglipron.
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.
