A new experimental GLP-1 drug, in pill form, could transform the weight loss drug boom. Eli Lilly’s new experimental pill called orforglipron, helped patients shed weight and control blood sugar as well as blockbuster drug Ozempic in a trial of diabetes patients, and the company said it expects to seek regulatory approvals by the end of the year, according to the pharmaceutical company.
The success of GLP-1 weight loss injectable drugs – Ozempic, the GLP-1 diabetes shot from Novo Nordisk, and Eli Lilly’s weight loss treatment Zepbound and diabetes drug Mounjaro – has set off an all-out push to develop a pill that’s easier to take and less expensive to make. The orforglipron pill would not require refrigeration, so it could be more affordable and accessible to more middle- or lower-income people, as well as a much more convenient option that would likely be more widely used.
Lilly said orforglipron is “the first oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist, taken without food and water restrictions, to successfully complete a Phase 3 trial,” in a statement.
Eli Lilly’s phase 3 trial of orforglipron has shown that type 2 diabetes patients lost 16 pounds, or nearly 8% of their body weight, over 40 weeks. This is comparable with Novo Nordisk’s injected drug Ozempic, which diabetic patients on the highest dose lost roughly 6% of their body weight.
There are three doses being tested: 3 mg, 12 mg and 36 mg.
The drugmaker is running Phase 3 studies on orforglipron for the treatment of type 2 diabetes and for weight management in adults with obesity or overweight with at least one weight-related medical problem. It is also being studied as a potential treatment for obstructive sleep apnea and hypertension in adults with obesity.
The most commonly reported adverse events were gastrointestinal-related and generally mild to moderate in severity. The most common adverse events for participants treated with orforglipron were gastrointestinal issues, including diarrhea, nausea, constipation and vomiting, and symptoms were “generally mild to moderate in severity,” according to the drugmaker.
Several drugmakers, including Novo Nordisk, are working to develop weight-loss medications in pill form. The latest data puts Eli Lilly firmly in the lead in the race for effective oral drugs that can compete with injections. Pfizer was forced to abandon its most advanced candidate after one patient in a clinical trial developed signs of liver injury. AstraZeneca is still working on its own weight-loss pills, with varying degrees of success.
Lilly said it expects to submit orforglipron for weight management to federal regulators in 2025 and for type 2 diabetes treatment in 2026, the company said in a statement, and, avoiding sweeping tariffs, would “make this medicine here in the United States,” said Chief Executive Officer Dave Ricks on Friday to Fox News.