Eli Lilly and Company has reported the first positive Phase 3 results for an oral small‑molecule GLP‑1 receptor agonist, marking a potential turning point in type 2 diabetes treatment.

In the 40‑week Achieve‑1 trial, adults with insufficient glucose control on diet and exercise saw their average A1C drop by 1.3% to 1.6% at the highest dose of orforglipron, the company said.

The trial enrolled 559 participants across the US, China, India, Japan and Mexico, all with a baseline A1C of around 8.0%. More than two‑thirds of those on the top dose reached an A1C of 6.5% or below, the threshold defined by the American Diabetes Association, Lilly reported.

In a key secondary measure, patients on the highest dose lost an average of 16 lbs—nearly 8% of body weight—by week 40, with data suggesting weight loss was still ongoing when the study ended.

Orforglipron is designed as a convenient, once‑daily pill that patients can take without food or water restrictions, potentially sidestepping the injection burden associated with current GLP‑1 therapies. The company said the safety profile was consistent with established injectable GLP‑1 drugs: most side effects were gastrointestinal, generally mild to moderate, and discontinuation rates remained low.

“This is the first of seven Phase 3 studies for orforglipron, and these results meet our expectations for glucose control, weight reduction and tolerability,” said David Ricks, Lilly’s chair and CEO. Lilly added that it has secured sufficient manufacturing capacity to launch orforglipron globally without delay, underscoring the company’s aim to tackle the projected 760 million adults who will have type 2 diabetes by 2050.

Industry experts say an oral GLP‑1 could boost patient adherence by removing the barriers of needles and refrigeration. “Having a pill option may increase uptake among people hesitant about injections,” noted diabetes specialist Dr. Paula Nguyen, who is unaffiliated with the study. “It could shift the treatment paradigm if safety and efficacy hold up in real‑world practice.”

Lilly plans to present the full Achieve‑1  data at the American Diabetes Association’s 85th Scientific Sessions and publish in a peer‑reviewed journal. Later this year, the company will report results from its ATTAIN weight‑management program, and it expects to file regulatory submissions for obesity indications by year’s end, with a diabetes application to follow in 2026.

If approved, orforglipron would be the first non‑peptide, oral GLP‑1 agonist on the market. The molecule was discovered by Chugai Pharmaceutical and licensed by Lilly in 2018. Beyond diabetes and weight management, Lilly is exploring orforglipron for sleep apnea and hypertension in people with obesity.

With these topline results, Lilly joins a growing field pursuing oral incretin therapies. But as the company presses ahead, trial stakeholders will be watching closely to see whether the convenience of a pill translates into sustained outcomes outside the clinic—and whether payers will recognise its value relative to established injectables.