By Robb M. Stewart

Eli Lilly's shares were rallying ahead of the opening bell after the drug company's first GLP-1 pill for diabetes and weight loss took a step closer to hitting the market.

In premarket trading, the shares were 12% higher after ending the previous session at $734.90. As of Wednesday's finish, the stock had fallen 4.8% so far in the new year and was 2.1% lower over the last 12 months.

Lilly said its investigational once-daily pill achieved positive topline results in a late-stage study evaluating the safety and efficacy of orforglipron compared with a placebo in adults with type 2 diabetes and inadequate glycemic control with diet and exercise alone.

Orforglipron is the first oral small molecule glucagon-like peptide-1, or GLP-1, receptor agonist 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 orforglipron worldwide without supply constraints. Lilly's injectable GLP-1 drug went into shortage just months after it was introduced for diabetes.

The efforts are part of Lilly's goal of targeting chronic diseases such as type 2 diabetes, which is expected to impact an estimated 760 million adults by 2050. Pill versions of popular GLP-1s for weight loss would also be much easier for physicians and patients than giving injections.

Lilly's Achieve-1 trial is the first of seven Phase 3 studies examining the safety and efficacy of orforglipron across people with diabetes and obesity.

The company said the first Phase 3 trial met the primary endpoint of superior A1C blood-sugar reduction compared with placebo at 40 weeks. In a key secondary endpoint, more than 65% of participants taking the highest dose of orforglipron achieved an A1C blood-sugar test less than or equal to 6.5%, which is below the American Diabetes Association's defined threshold for diabetes.

Lilly said that in an additional key secondary endpoint, participants taking orforglipron lost an average of 16 pounds at the highest dose. Given that participants hadn't yet reached a weight plateau at the time the study ended, it appears that full weight reduction wasn't yet attained, it said.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

April 17, 2025 07:37 ET (11:37 GMT)

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