FDA approves Lilly's Foundayo (orforglipron) for adults with obesity or overweight; an oral GLP-1 receptor agonist that can be taken any time of day without food or water restrictions.

Eli Lilly and Company (NYSE: LLY) said Foundayo™ (orforglipron) is now available to adults with obesity or overweight with weight-related medical problems, following FDA approval on April 1, 2026. The company said the once-daily pill, used alongside a reduced-calorie diet and increased physical activity, is intended to help patients lose excess body weight and keep it off.

Foundayo can be taken without food or water restrictions. Lilly said access is available through LillyDirect® and telehealth providers, with availability expanding to U.S. retail pharmacies beginning April 9, 2026.

Pricing and access

Lilly said Foundayo is available starting at $149 per month at the lowest dose for self-pay patients. The company also said eligible commercially insured patients may pay as little as $25 per month with the Foundayo savings card.

For eligible Medicare Part D individuals, Lilly said the cost may be $50 per month beginning July 1, 2026. The company directed readers to www.foundayo.lilly.com to review options.

Clinical trial results

Lilly said Foundayo was supported by its ATTAIN clinical trial program. In the ATTAIN-1 trial, participants taking the highest dose and staying on treatment lost an average of 27.3 pounds (12.4%) versus 2.2 pounds (0.9%) with placebo.

The company said participants taking Foundayo, regardless of trial completion, lost an average of 25 pounds (11.1%) compared with 5.3 pounds (2.1%) with placebo.

Lilly also said the ATTAIN program showed reductions in multiple cardiovascular risk markers, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.

Trial program scope

Lilly said the ATTAIN Phase 3 global clinical development program enrolled more than 4,500 people with obesity or overweight across two global registration trials.

ATTAIN-1

Lilly said ATTAIN-1 (NCT05869903) was a 72-week Phase 3 randomized, double-blind, placebo-controlled trial comparing orforglipron at various doses with placebo in adults with obesity or overweight who had at least one comorbidity, including hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, and who did not have diabetes.

The company said the trial randomized 3,127 participants across the U.S., Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan to receive various doses of orforglipron or placebo alongside a healthy diet and physical activity. Lilly said the primary objective was to demonstrate that orforglipron was superior to placebo in body weight reduction from baseline after 72 weeks.

ATTAIN-2

Lilly said ATTAIN-2 (NCT05872620) was a 72-week Phase 3 randomized, double-blind, placebo-controlled trial comparing various doses of orforglipron with placebo in adults with obesity or overweight and type 2 diabetes.

The company said the trial randomized over 1,600 participants across the U.S., Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico to receive various doses of orforglipron or placebo alongside a healthy diet and physical activity. Lilly said the primary objective was to demonstrate that orforglipron was superior to placebo in mean body weight change from baseline at 72 weeks.

Safety and prescribing warnings

Lilly said Foundayo is not recommended for use with other GLP-1 receptor agonist medicines. The company also said it is not known whether Foundayo is safe and effective for use in children.

Lilly warned that Foundayo may cause tumors in the thyroid, including thyroid cancer, and advised patients to watch for symptoms such as a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath.

The company said Foundayo should not be used by people with a history of type of thyroid cancer called medullary thyroid carcinoma (MTC), by people with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), or by those who have had a serious allergic reaction to orforglipron or any ingredients in Foundayo.

Lilly said the medicine may cause serious side effects including pancreatitis, severe stomach problems, dehydration leading to kidney problems, hypoglycemia, serious allergic reactions, changes in vision in patients with type 2 diabetes, gallbladder problems, and risk of aspiration during anesthesia.

The company listed common side effects as nausea, constipation, diarrhea, vomiting, indigestion, abdominal pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss.

Obesity medicine access

Lilly said obesity remains one of the few major chronic diseases without consistent insurance coverage across U.S. health plans. The company said approximately half of Americans with employer-sponsored insurance lack coverage for obesity management medications.

As part of its stated effort to expand obesity medicine access and improve affordability, Lilly said it expanded self-pay access for individual patients.

About Foundayo

Lilly said Foundayo is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight reduction long term alongside a reduced-calorie diet and increased physical activity.

The company described Foundayo as a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.

Lilly said orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. The company said orforglipron is being studied in clinical trials for other conditions including type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.