Eli Lilly reported encouraging results Thursday from the first late-stage clinical trial of its oral weight-loss and diabetes drug, orforglipron, pushing shares of the pharmaceutical giant up more than 11% in premarket trading. The company said its experimental pill helped patients with Type 2 diabetes lose up to 7.9% of their body weight over 40 weeks and showed strong safety and efficacy results, positioning the drug as a major contender in the fast-growing GLP-1 market.
The trial results come as investors and analysts closely watch the obesity drug space, which is projected to exceed $150 billion in annual sales by the early 2030s. Eli Lilly, already a dominant player with its injectable Mounjaro and Zepbound, is aiming to extend its lead by offering a daily, needle-free alternative to rival drugs like Novo Nordisk's Ozempic and Wegovy.
At the highest dose tested, patients lost an average of 16 pounds, or 7.9% of their body weight. The company noted that patients continued to lose weight through the end of the 40-week study period, suggesting further reduction is possible. The pill also lowered hemoglobin A1c levels, a key diabetes marker, by 1.3% to 1.6%, compared to a 0.1% decline in the placebo group. Some analysts, however, had expected reductions closer to 2%.
Side effects - primarily gastrointestinal - were generally consistent with other GLP-1 therapies. The most common were nausea (up to 18% of patients), diarrhea (up to 26%), and vomiting (up to 14%). Discontinuation at the highest dose was 8%, slightly below TD Cowen's projected 9%.
CEO David Ricks stated, "As a convenient once-daily pill, orforglipron may provide a new option and, if approved, could be readily manufactured and launched at scale." The non-peptide design of orforglipron sets it apart from injectable GLP-1s, enabling easier absorption and fewer dietary restrictions.
The trial results surpassed Wall Street expectations for weight loss and safety, although some metrics fell short of more aggressive forecasts. Still, the data supports Lilly's plans to submit the drug for regulatory approval for obesity by the end of 2025, with diabetes approval expected in 2026.
In contrast to hormone-based GLP-1s, orforglipron is a synthetic small molecule, allowing for simpler production and global scalability. The company has already begun stockpiling supplies in anticipation of approval.
Shares of Novo Nordisk and Viking Therapeutics, which are also pursuing oral GLP-1 candidates, fell after the announcement. Meanwhile, Pfizer recently discontinued its own pill, danuglipron, citing potential liver injury in trials - a setback that Lilly said it has not encountered with orforglipron.
