The company said that it now has the full clinical data package required to initiate global regulatory submissions for Orforglipron.
Eli Lilly and Company (LLY) announced on Tuesday that its oral weight-loss drug candidate Orforglipron delivered significant weight loss, meaningful average blood glucose reduction, and improvements in cardiometabolic risk factors at 72 weeks in a late-stage trial.
At the highest dose of 36 mg, Orforglipron, taken once per day without food and water restrictions, lowered weight by an average of 10.5% compared to 2.2% with placebo, the company said. The trial studied three doses of Orforglipron in over 1,600 adults with obesity or overweight and type 2 diabetes.
Lilly said that it now has the full clinical data package required to initiate global regulatory submissions for Orforglipron.
On Stocktwits, retail sentiment around LLY stock stayed within ‘bearish’ territory over the past 24 hours, while message volume stayed at ‘low’ levels. LLY stock traded 2.5% higher in the pre-market session at the time of writing.
The company said that at 72 weeks, Orforglipron lowered blood sugar levels by 1.3% to 1.8% from a baseline of 8.1% across three doses in the study. Furthermore, at its lowest dose of 6 mg, Orforglipron still delivered a 5.5% average reduction in weight, the company said.
“With these positive data in hand, we are moving with urgency toward global regulatory submissions to potentially meet the needs of patients who are waiting,” said Kenneth Custer, Lilly executive vice president and president of Lilly Cardiometabolic Health.
The overall safety profile of Orforglipron in the trial was consistent with established GLP-1 receptor agonist class drugs, the company said. The most commonly reported adverse events were gastrointestinal-related and generally mild-to-moderate in severity.
The company noted that 6.1% to 10.6% of participants in the study discontinued treatment across doses due to adverse events, as compared to 4.6% with placebo. Overall treatment rates were between 19.1% to 20.5% in patients who received the oral weight loss drug, as compared to 20% with placebo.
With Orforglipron, Lilly is attempting to expand its impact in the obesity treatment market dominated by GLP-1 injections. 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.
LLY stock is down by 10% this year and by about 27% over the past 12 months.
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