Eli Lilly’s Orforglipron Wins FDA Approval for Weight Loss

Eli Lilly’s weight loss pill, orforglipron, received FDA approval on April 1.

The oral GLP-1 receptor agonist is indicated for long-term weight management alongside diet and exercise in adults with obesity or overweight and at least one related condition.

Prescriptions are now being accepted, with shipments set to begin April 6. The drug starts at 0.8 mg daily and should not be combined with other GLP-1 treatments.

In two Phase III ATTAIN trials, patients taking the highest dose lost over 12% of body weight versus about 1% in placebo groups. On average, users saw a 10% reduction, compared to 2% for those on placebo.

Cardiovascular markers such as waist size, non-HDL cholesterol, triglycerides, and blood pressure also improved.

Eli Lilly plans to launch orforglipron in more than 40 countries, including for Type 2 diabetes use.

“This is obesity care designed for the real world,” said David A. Ricks, CEO of Eli Lilly.

Dr. Deborah Horn of UTHealth Houston noted the convenience factor: “A once-daily pill without food or water restrictions offers greater flexibility.”