The US FDA approved Eli Lilly and Company’s oral GLP-1 receptor agonist orforglipron (Foundayo) on April 1, 2026 for chronic weight management in adults with obesity, or those who are overweight with at least one weight-related condition, alongside a reduced-calorie diet and increased physical activity. The approval marks Lilly’s second cleared obesity medicine and establishes orforglipron as the first non-peptide small-molecule GLP-1 receptor agonist to reach the US market for weight management, following Novo Nordisk’s peptide-based oral semaglutide, which was approved in 2025.
Orforglipron is available as a once-daily oral tablet across multiple dose strengths ranging from 0.8 mg to 17.2 mg. The drug can be taken at any time of day without food or water restrictions, a formulation advantage over oral semaglutide, which requires specific fasting and fluid conditions. Lilly said it will make the drug available through its LillyDirect platform beginning April 6, with subsequent rollout through US retail pharmacies and telehealth providers. The company said eligible patients with commercial insurance could access the drug for as little as USD 25 per month, with a self-pay price starting at USD 149 per month for the lowest dose.
Pivotal data readouts
The approval was supported by the ATTAIN Phase III clinical development program, which enrolled more than 4,500 participants across two global registration trials. ATTAIN-1 (NCT05869903) was a 72-week, randomized, double-blind, placebo-controlled trial in 3,127 adults with obesity or overweight with at least one comorbidity — hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease — who did not have diabetes.
The primary objective was superiority over placebo in body weight reduction from baseline at 72 weeks. Participants receiving the highest dose lost an average of 27.3 pounds (12.4%) at 72 weeks, compared with 2.2 pounds (0.9%) with placebo. Across all randomized participants, mean weight loss was 25 pounds (11.1%) versus 5.3 pounds (2.1%).
The ATTAIN program also enrolled a second trial, ATTAIN-2 (NCT05872620), which evaluated orforglipron in more than 1,600 adults with obesity or overweight and type 2 diabetes over the same 72-week period. Lilly said treatment was also associated with reductions in waist circumference, non-HDL cholesterol, triglycerides, and systolic blood pressure across doses. The safety profile was consistent with the GLP-1 receptor agonist class, with the most common adverse events including nausea, constipation, diarrhea, vomiting, and related gastrointestinal effects. The prescribing information includes a warning regarding thyroid tumors and contraindications in patients with a personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.