Eli Lilly (NYSE: LLY) Plans to Submit a Biologics License Application (BLA) for Retatrutide (Once-Weekly Injectable GIP/GLP-1/Glucagon Triple Hormone Receptor Agonist Peptide) to the FDA in Q1 2027 Following the July 23, 2026 TRIUMPH-2 and TRIUMPH-3 Phase 3 Readouts, With TRIUMPH-2 in 1,152 Adults With Obesity and Type 2 Diabetes Documenting Up to 20.8% Mean Weight Loss and 1.6 Percentage Point HbA1c Reduction and TRIUMPH-3 Confirming Similar Efficacy Profiles Across an Additional Patient Population; TRIUMPH-1 (Obesity Without Diabetes) Delivered 28.7% Mean Weight Loss at 68 Weeks at the 12 mg Dose and TRIUMPH-4 (Obesity Plus Knee Osteoarthritis) Delivered 28.7% Weight Loss With 75.8% Reduction in WOMAC Pain Scores; Potential FDA Approval Expected in 2027-2028 With Retatrutide Positioned to Set the New Weight-Loss Ceiling in the Obesity Drug Class
Eli Lilly (NYSE: LLY) plans to submit a Biologics License Application (BLA) for retatrutide (once-weekly injectable GIP/GLP-1/glucagon triple hormone receptor agonist peptide) to the FDA in Q1 2027 following the July 23, 2026 TRIUMPH-2 and TRIUMPH-3 Phase 3 readouts. TRIUMPH-2 (obesity and type 2 diabetes) enrolled 1,152 adults and documented up to 20.8% mean weight loss and 1.6 percentage point HbA1c reduction at 68 weeks. TRIUMPH-3 confirmed similar efficacy profiles across an additional patient population. Combined with the earlier readouts (TRIUMPH-1 in obesity without diabetes at 28.7% mean weight loss at 68 weeks at the 12 mg dose, and TRIUMPH-4 in obesity plus knee osteoarthritis at 28.7% weight loss with 75.8% reduction in WOMAC pain scores), the retatrutide package now covers four major indication frames with consistent efficacy. Additional TRIUMPH readouts expected across 2026 in obstructive sleep apnea, chronic lower back pain, and cardio-renal-metabolic outcomes will strengthen the label breadth. Potential FDA approval is expected in 2027-2028, positioning retatrutide to set the new weight-loss ceiling in the obesity drug class at 28.7% (versus tirzepatide's 25.5% and semaglutide's 15% in the current approved landscape).