In this articleLLYFollow your favorite stocksCREATE FREE ACCOUNTEli Lilly Biotechnology Center is shown in San Diego, California, U.S. March 1, 2023. Mike Blake | ReutersEli Lilly on Tuesday said its daily weight loss pill helped patients with obesity and Type 2 diabetes shed weight in a late-stage trial, meeting the study’s main goal and clearing the way for the company to file for approval of the drug globally. The treatment is inching closer to becoming a new, needle-free alternative in the highly lucrative market for weight loss and diabetes drugs called GLP-1s. More convenient pills could boost supply for the treatments and make them easier to access than the pricey weekly injections currently dominating the space. The Eli Lilly pill also would not come with dietary restrictions, in contrast to a similar oral treatment from chief rival Novo Nordisk.The highest dose of the pill, orforglipron, helped patients lose 10.5% of their weight, or 22.9 pounds, on average at 72 weeks, compared to 2.2% weight loss among those who took a placebo. The drug’s weight loss in the study was 9.6% when analyzing all patients regardless of discontinuations. Eli Lilly’s pill met the trial’s other goals of helping patients lower their hemoglobin A1c, a measure of blood sugar levels. By the end of the study, most patients no longer met the criteria for Type 2 diabetes based on that metric. The rate of side effects and treatment discontinuations in the study, called ATTAIN-2, appeared to be generally consistent with two recent phase three trials on Eli Lilly’s drug. Eli Lilly said it now has the full clinical trial data package required to file for approvals of the drug for chronic weight management with global regulators. The pharmaceutical giant expects to launch the pill around the world “this time next year,” CEO David Ricks told CNBC in early August. In an interview, Eli Lilly’s Chief Scientific Officer Daniel Skovronsky, said the pill had “unprecedented efficacy” in patients with obesity and Type 2 diabetes, who typically have a more difficult time losing weight compared to those without diabetes. Skovronsky said he hopes that diabetes patients will be able to use the pill earlier in their disease to slow down its progression. Existing GLP-1 injections have shown greater weight loss than Eli Lilly’s pill, but having an oral option that offers more than 10% for patients with both obesity and Type 2 diabetes is “actually very good, so that’s positive,” said Dr. Caroline Apovian, co-director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital.But she called it “concerning” that more patients – 10.6% of those on the highest dose – stopped taking the pill due to side effects compared with what has been seen in separate studies on the existing injections, Eli Lilly’s Zepbound and Novo Nordisk’s Wegovy. Apovian said patients and their prescribers will have to weigh the risks and benefits of the pill and the injections when deciding which to take, including convenience, side effects and efficacy. The side effects of Eli Lilly’s pill were mainly gastrointestinal, such as nausea and vomiting, and were mild to moderate in severity. An estimated 23.1% of those who took the highest dose experienced vomiting, while 36.4% and 27.4% had nausea and diarrhea, respectively.Around 20% of patients stopped taking the pill for any reason, which is roughly the same rate as th …
