It looks likely we'll see oral GLP-1 drugs on the market by next year, with pharmaceutical company Eli Lilly reporting impressive results following a large, robust 72-week trial that saw obese participants lose an average of 27.3 lb, or 12.4% of their body weight with the once-daily pill.
This week the company announced positive results from its Phase 3 ATTAIN-1 trial of the GLP-1 receptor agonist known as orforglipron, given to 3,127 adults with obesity over 72 weeks. In the long study, all doses passed their efficacy and tolerability benchmarks compared to a placebo, with clinically significant results across the board.
Now, the US drug maker is set to apply for global approval of orforglipron by the end of 2025, meaning it's likely to be the first oral weight-loss drug in this class and likely to be on offer in the new year.
"Obesity is one of the most pressing global health challenges of our time, driving global chronic disease burden and impacting more than one billion people worldwide," said Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health. "With orforglipron, we're working to transform obesity care by introducing a potential once-daily oral therapy that could support early intervention and long-term disease management, while offering a convenient alternative to injectable treatments."
"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.
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. What's more, 39.6% lost at least 15% of their body weight. Orforglipron also significantly lowered cardiovascular disease risk, including non-HDL cholesterol, triglycerides and systolic blood pressure.
Much like current GLP-1 injections, oral orforglipron was well tolerated, with the main side-effects being gastrointestinal-related and mild-to-moderate severity. Importantly, treatment discontinuation on all three doses was lower than those taking the placebo.
The detailed results will be presented next month at the European Association for the Study of Diabetes (EASD) Annual Meeting 2025, before being published in a peer-reviewed journal for closer scrutiny. So too will the results of the Phase III clinical trial assessing orforglipron in treating type 2 diabetes.
The once-daily pill would be an alternative treatment option to the company's Zepbound, which is currently a weekly injectable medication for obesity.
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.
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.
Source: Eli Lilly
