Eli Lilly and Company has received FDA approval for Foundayo (orforglipron), the first oral GLP-1 for weight loss that has no food or water restrictions.
Foundayo is a small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist. Lilly licensed the drug from Chugai Pharmaceutical in 2018. The once-daily pill is now approved for adults with obesity or overweight with a weight-related medical condition. It is unknown whether the medication is safe and effective for pediatric use.
In the ATTAIN-1 clinical trial, patients taking the highest dose in combination with a reduced-calorie diet and increased exercise lost an average of 27.3 pounds (12.4%), whereas a placebo led to weight loss of just 2.2 pounds (0.9%). All doses also led to a reduction in waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure.
Lilly's Foundayo will go head-to-head against with Novo Nordisk's oral Wegovy, approved in late December 2025. The FDA approved Novo's weight loss pill based on the Oasis 4 phase 3 trial that showed an average weight loss of 16.6% when taking 25 mg tablets in conjunction with a reduced-calorie diet and exercise. In comparison, the average weight loss with the placebo was 2.7%. Patients in the 64-week trial were either obese or overweight with a weight-related comorbidity but without diabetes.