Daily GLP-1 pill effective for diabetes and obesity, Eli Lilly says
A daily pill from drugmaker Eli Lilly has shown safety results comparable to the leading injectable GLP-1 drugs Mounjaro and Ozempic, the company announced Thursday.
The once-daily pill, called orforglipron, helped patients with Type 2 diabetes lower their drug sugar levels and lose weight during late-stage trials, the drugmaker said.
The trial results are being closely watched, as a needle-free anti-obesity drug could give Lilly a major edge over its well-established rivals.
GLP-1s are a class of drugs that have become blockbusters for the way they help people lose weight. But they are expensive, must be refrigerated and are delivered through an injection. A daily pill version could make the drugs much more accessible.
According to Lilly, orforglipron is the first oral small molecule GLP-1, taken without food and water restrictions, to successfully complete a Phase 3 trial. If approved, the company said it is confident in its ability to launch the drug worldwide without supply constraints.
The trial randomized 559 participants across the U.S., China, India, Japan and Mexico and measured the drug's efficacy and safety in adults with Type 2 diabetes compared to a placebo.
The 40-week trial found the pill lowered blood sugar levels, measured by A1C, by an average of 1.3 to 1.6 percent across different doses from a starting level of 8 percent.
More than 65 percent of participants taking the highest dose dropped their A1C levels to the normal range, below what is considered diabetic.
In addition, participants lost an average of 16 pounds at the highest dose of the drug without reaching a plateau at the end of the trial, meaning full weight reduction was not yet attained. But like most drugs in the class, weight loss is expected to be much less in people with diabetes compared to those with obesity.
The overall safety profile was consistent with the established GLP-1 class. Side effects were the same as those with the injectable obesity drugs — diarrhea, indigestion, constipation, nausea and vomiting.
The company did not include information on the demographics of the people who participated in the trial.
The results will be presented at the annual meeting of the American Diabetes Association's Scientific Sessions and will be published in a peer-reviewed journal.
There are seven late-stage studies examining the safety and efficacy of the pill across people with diabetes and obesity. The company expects to file for regulatory approval of the pill for obesity by the end of the year, and for treatment of diabetes in 2026.
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