Eli Lilly is set to request approval for obesity pill after successful trial

A new weight loss pill could soon be on the market. 

Eli Lilly, a pharmaceutical company, said it is ready to submit its obesity pill orforglipron for global regulatory approval after a successful phase 3 in its ATTAIN-2 trial, according to a press release published Tuesday.

It said the drug met the “primary and all key secondary endpoints” in the study, which tested the oral GLP-1 in adults who are overweight or obese and adults who have type 2 diabetes, and now has “the full clinical data package required to initiate global regulatory submissions for orforglipron.” 

"With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting,” Kenneth Custer, Eli Lilly’s executive vice president and president of Lilly Cardiometabolic Health, said in the release. “If approved, we are ready to offer a convenient, once-daily pill that can be scaled globally — removing barriers and redefining how obesity is treated around the world."

The pharma company said the trial met its primary endpoint with testing of the drug’s highest dose. When participants took 36 mg of the drug daily for 72 weeks, the study found it lowered participants' weight by 10.5% — or 22.9 lbs — on average compared to 2.2% — or 5.1 lbs —- for those who used a placebo. 

The study also found that the drug lowered A1C by 1.3% to 1.8% from a baseline of 8.1% across doses plus 75% of users taking the drug’s highest dose got an A1C at or below 6.5% — which the study said is the American Diabetes Association’s definition of the disease — for two of its secondary endpoints. 

The company said its trial also found that its weight loss drug showed “clinically meaningful benefits” for major cardiovascular risk factors like non-HDL cholesterol, systolic blood pressure, and triglycerides. It also showed in a “pre-specified exploratory analysis” that the drug’s highest dose lowered a marker of inflammation by about 50%. 

Eli Lilly’s stock was up more than 4% in morning trading, while competitor Novo Nordisk, maker of Ozempic, was down nearly 3%. 

Last week, Novo Nordisk announced a cash discount for uninsured Ozempic users. The Danish pharma company’s new cash discount came weeks after it posted second-quarter earnings below Wall Street's expectations as it battles fierce competition from Eli Lilly and compounders making copycat GLP-1 drugs at more accessible prices.

Eli Lilly had also gone after knockoffs of its weight loss products earlier this year, launching an advertising campaign in March about the riskiness of using such copycat drugs.