FDA Approval

FDA Approves Orforglipron (Foundayo) for Chronic Weight Management

Edited by:
Anthony Calabro, MA

Key Highlights

  • The FDA approved orforglipron (Foundayo) for chronic weight management in adults.
  • The approval was supported by the phase 3 ATTAIN clinical trial program.
  • In ATTAIN-1, mean weight loss reached 12.4% (27.3 lb) vs 0.9% (2.2 lb) with placebo.
  • The most common adverse events were gastrointestinal, including nausea and diarrhea.

On April 1, 2026, the FDA approved Foundayo (orforglipron), a once-daily, small-molecule, nonpeptide oral glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management in adults with obesity or those who are overweight with at least 1 weight-related medical condition. The drug is indicated for use alongside a reduced-calorie diet and increased physical activity. Orforglipron can be taken at any time of day, regardless of food or water intake. It is not known whether orforglipron is safe and effective in children.

The approval was supported by the phase 3 ATTAIN clinical trial program, including ATTAIN-1, a 72-week, randomized, double-blind, placebo-controlled trial in adults with obesity or overweight without diabetes. The study enrolled 3,127 participants across multiple countries, with the primary endpoint of change in body weight from baseline at 72 weeks. Participants receiving the highest dose of orforglipron who remained on treatment experienced a mean weight reduction of 27.3 lb (12.4%) compared with 2.2 lb (0.9%) with placebo. Across all participants, regardless of treatment adherence, the mean weight loss was 25 lb (11.1%) with orforglipron vs 5.3 lb (2.1%) with placebo.

The most common adverse events reported with orforglipron were gastrointestinal, including nausea, constipation, diarrhea, vomiting, indigestion, and abdominal pain. Other reported adverse events included headache, fatigue, bloating, belching, heartburn, gas, and hair loss. The drug carries a warning for the risk of thyroid tumors, including thyroid cancer. It should not be used in patients with a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

Additional risks include pancreatitis, gallbladder disease, hypoglycemia (particularly with concomitant insulin or sulfonylureas), kidney complications related to dehydration, and hypersensitivity reactions.

Orforglipron is administered orally once daily, with or without food. Tablets should be swallowed whole and not split, crushed, or chewed. It is available in multiple dose strengths ranging from 0.8 mg to 17.2 mg.

Reference
Eli Lilly and Company. FDA approves Lilly’s Foundayo (orforglipron) for chronic weight management. News release. April 1, 2026. Accessed April 2, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill