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Eli Lilly and Company (LLY) on Thursday said that its investigational oral weight-loss drug lowered weight by an average of 12.4% in a late-stage study at its highest dose.
The once-daily oral pill called Orforglipron showed significant efficacy, and a safety and tolerability profile consistent with injectable GLP-1 therapies such as Lilly’s Mounjaro at 72 weeks, the company said.
Lilly evaluated three doses of Orforglipron in the study. All three doses delivered clinically meaningful weight loss as an adjunct to a healthy diet and physical activity, the company said. While patients on the highest dose of 36 mg lost an average of 27.3 lbs in the trial at 72 weeks, those on the lowest dose of six mg lost about 17.6 lbs. Notably, 59.6% patients on the highest dose lost at least 10% of their body weight, and 39.6% lost at least 15%.
The trial was conducted in 3,127 adults with obesity or overweight with a weight-related medical problem, and without diabetes. Over 24% patients discontinued treatment at the highest doses compared to nearly 30% with placebo in the trial, the company added. Following the release of the results, Eli Lilly shares tumbled nearly 8% in Thursday’s pre-market session.
The most commonly reported adverse events in the trial were gastrointestinal-related and generally mild-to-moderate in severity, Lilly noted.
Kenneth Custer, executive vice president and president of Lilly Cardiometabolic Health, said that the company is now planning to submit Orforglipron for regulatory approval by the end of the year.
On Stocktwits, retail sentiment around LLY jumped from 'bullish' to 'extremely bullish' over the past 24 hours, accompanied by 'high' message volume.
Orforglipron was discovered by Chugai Pharmaceutical Co., and licensed by Lilly in 2018. Lilly is also studying the drug in the treatment of type 2 diabetes, in addition to weight management, and as a potential treatment for obstructive sleep apnea (OSA) and hypertension in adults with obesity.
Lilly on Thursday also increased the midpoint of its 2025 full-year revenue guidance by $1.5 billion to be in the range of $60 billion to $62 billion and now expects full-year adjusted earnings per share (EPS) to be in the range $21.75 to $23.00.
For the second quarter, the company’s revenue came in at $15.56 billion, marking a growth of 38% and beating an analyst estimate of $14.67 billion, driven by robust sales of its GLP-1 drugs Zepbound and Mounjaro.
The company recorded $5.20 billion in revenue from Mounjaro in the three months through the end of June and $3.38 billion from its diabetes drug Zepbound. Strong demand for the drugs was partially offset by lower realized prices, the company said.
Adjusted EPS came in at $6.31, above an analyst estimate of $5.59, as per data from Fiscal AI.
LLY stock is down by 3% this year and over the past 12 months.
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