Eli Lilly shares surged 11.4% to a record $920 on Friday after the company reported pivotal Phase 3 trial results showing its once-daily oral GLP-1 receptor agonist orforglipron delivered an average 16.2% weight loss at 72 weeks in patients with obesity, decisively beating the 12.4% threshold set by Wall Street and meeting all 14 secondary endpoints, including cardiovascular outcomes.
The breakthrough positions Lilly to launch the world's first effective oral weight-loss drug, eliminating the injection requirement that has limited adoption of injectable GLP-1s like Ozempic, Wegovy, and Mounjaro. Lilly disclosed it plans to file for FDA approval before the end of June, with a potential commercial launch in Q1 2027 if the agency grants priority review.
Cardiovascular Benefits Confirmed
Beyond weight loss, the trial demonstrated a 28% reduction in major adverse cardiovascular events versus placebo over the 72-week period — broadly comparable to the cardiovascular benefit shown by injectable semaglutide in the SELECT trial that supported the Wegovy CVD label. The data should support reimbursement by Medicare under the recent Inflation Reduction Act provisions covering obesity drugs with proven cardiovascular benefit.
Side-effect profile was broadly consistent with injectable GLP-1s, with gastrointestinal events including nausea (32%), diarrhea (24%), and vomiting (16%) the most common adverse events. Discontinuation rates due to side effects were 9.4%, slightly lower than the 11-12% rate observed in Wegovy and Zepbound trials. No new safety signals emerged.
Novo Nordisk Falls Sharply
The competitive implications drove sharp moves elsewhere in the obesity-drug space. Novo Nordisk shares fell 6.8% in Copenhagen as investors worried that orforglipron's convenience advantage will accelerate share losses already underway. Novo's own oral semaglutide candidate is not expected to file until 2027 and uses a higher 25mg dose with mandatory fasting requirements that compromise convenience.
Bank of America analyst Geoff Meacham raised his Lilly price target to $1,150 from $1,000, modeling orforglipron peak sales of $32 billion by 2031. Goldman Sachs' Asad Haider lifted his target to $1,080 and forecasts orforglipron will capture 38% of the global oral-GLP-1 market by 2030. Lilly's market cap now stands at $874 billion, making it the third-largest U.S. healthcare company.