Eli Lilly seeks approval for once‑daily oral weight‑loss pill after positive trial results

Eli Lilly said it plans to seek regulatory approval for an investigational once‑daily oral weight‑loss pill after late‑stage trial results showed significant reductions in body weight.

In a study of 3,127 adults who were obese or overweight with at least one weight‑related medical condition and did not have diabetes, participants taking the experimental drug, orforglipron, lost an average of 12.4% of their body weight over 72 weeks compared with placebo, the company said. Lilly has indicated it intends to submit the medicine for regulatory review by the end of the year and has said the pill could be available in some countries as early as next year if approved.

Orforglipron targets the same glucagon‑like peptide‑1 (GLP‑1) receptors as popular injectable weight‑loss drugs such as semaglutide (branded Wegovy and Ozempic) and tirzepatide (branded Mounjaro). GLP‑1 receptor agonists suppress appetite and increase feelings of fullness. Lilly executives have framed the oral therapy as a potentially more convenient alternative for people who are reluctant to use weekly injections.

Company statements and reporting said the pill can be stored at room temperature and taken at any time of day, with or without food, which could simplify distribution and use compared with injectable formulations. Lilly has not announced a final price for the medicine, but reporting has suggested the oral formulation may be cheaper to produce and transport than injectables. Industry commentary cited in reporting has placed potential market value for oral GLP‑1 therapies in the tens of billions of dollars by the end of the decade.

Lilly acknowledged side effects similar to those reported for injectable GLP‑1 therapies. Trial data released by the firm showed that about one in four participants experienced diarrhea and roughly one in six reported nausea. There have also been reported instances of pancreatitis among some patients taking the drug, the company said. The company said it will present full safety and efficacy data to regulators as part of its submission package.

Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said the company viewed an oral GLP‑1 as a tool to support earlier intervention and long‑term disease management for obesity. Lilly’s chief executive, Patrik Jonsson, has said the company is also researching longer‑acting approaches in obesity care, though he described a “once‑and‑done” cure as years away.

The push to expand oral options for weight management comes amid heightened public interest in GLP‑1 receptor therapies and concerns about access and cost. In recent weeks, Lilly scaled back plans to increase the list price of Mounjaro after reaching commercial arrangements with pharmacists and private providers intended to limit price rises for patients. Under those arrangements, reporting said the top dose of Mounjaro will cost about £247.50, lower than a previously announced list price, with smaller discounts for lower strengths. The company said it was working with providers to maintain affordability and that providers were responding to the list‑price change in different ways.

Regulators will review Lilly’s full data package, including long‑term safety findings, before any approvals are granted. If authorised, orforglipron would join a growing set of GLP‑1 therapies used to treat obesity and weight‑related conditions, offering an oral option that company officials and some clinicians say could broaden treatment uptake among people who prefer pills to injections.

Independent experts and regulators will assess whether the benefits seen in the trial outweigh the risks for the populations studied, and whether the therapy should be made available for broader groups. Lilly has said it is prepared for a global launch if regulators grant approval.