Aug 27, 11:14 AM

Lilly’s Oral Obesity Pill Clears Phase 3, Eyes 2025 FDA Submission

Eli Lilly reported that its once-daily oral obesity pill, orforglipron, achieved all primary and key secondary endpoints in the late-stage ATTAIN-2 study, clearing the last clinical hurdle before regulatory filings. The company said the dataset now enables it to submit applications to the U.S. Food and Drug Administration and other regulators later this year, positioning orforglipron to become the first next-generation oral GLP-1 therapy for weight management. The 72-week trial enrolled more than 1,600 adults with obesity or overweight and type-2 diabetes across 10 countries. Patients taking the highest 36-mg dose lost an average 10.5% of body weight—about 22.9 pounds—compared with 2.2% for placebo, and lowered hemoglobin A1C by 1.8 percentage points from a baseline 8.1%. Three-quarters of participants on the top dose achieved an A1C of 6.5% or below, a common threshold for diabetes control. Gastrointestinal side effects were generally mild to moderate and in line with other GLP-1 drugs. Orforglipron’s oral formulation could broaden access to the fast-growing obesity-drug market now dominated by injectable GLP-1 agents such as Novo Nordisk’s Wegovy. Lilly licensed the compound from Japan’s Chugai Pharmaceutical, whose shares jumped on the announcement, while Lilly shares recouped losses posted after an earlier read-out of the same program. If regulators approve the drug, Lilly says its manufacturing network is prepared to scale global supply.

#Eli Lilly #Novo Nordisk #Wegovy #Lilly #Japan #Chugai Pharmaceutical

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Lilly’s Oral Obesity Pill Clears Phase 3, Eyes 2025 FDA Submission

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