INDIANAPOLIS, July 23, 2026
Eli Lilly and Company has announced positive topline results from the Phase 3 TRIUMPH-2 and TRIUMPH-3 clinical trials, demonstrating that its investigational triple hormone receptor agonist, retatrutide, delivered substantial weight loss, improved glycemic control, and favorable cardiometabolic outcomes in adults with obesity and serious obesity-related conditions. The studies met their primary endpoints, with participants achieving up to 22.6% average weight loss (55.8 pounds) over 80 weeks, while adults with type 2 diabetes also experienced A1C reductions of up to 1.6%. These results further strengthen Lilly’s obesity and metabolic disease portfolio and complete the clinical package supporting planned global regulatory submissions for retatrutide. The company expects to submit a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the first quarter of 2027, positioning the investigational therapy as a potential first-in-class treatment for obesity and multiple cardiometabolic conditions.
TRIUMPH Studies Demonstrate Significant Weight Loss and Glycemic Benefits
The TRIUMPH-2 trial evaluated retatrutide in adults living with obesity or overweight and type 2 diabetes, a population often facing greater challenges achieving meaningful weight reduction. Across the three treatment doses, participants experienced average weight loss ranging from 12.7% to 20.8%, with the highest-dose group losing an average of 49.6 pounds after 80 weeks of treatment. Alongside these weight reductions, patients achieved clinically meaningful improvements in blood sugar control, with A1C reductions of up to 1.6%, highlighting the therapy’s dual impact on obesity and diabetes management. Meanwhile, the TRIUMPH-3 study enrolled adults with severe obesity and established cardiovascular disease, with or without type 2 diabetes, where participants receiving the highest retatrutide dose achieved 22.6% average weight loss, equivalent to 55.8 pounds. Both pivotal studies successfully met their primary efficacy endpoints, reinforcing the potential of retatrutide to address complex metabolic disorders through a single investigational therapy.
Triple Hormone Agonist Shows Broad Cardiometabolic Potential
Unlike currently available therapies that primarily target one or two metabolic pathways, retatrutide is a once-weekly investigational triple hormone receptor agonist that simultaneously activates GIP, GLP-1, and glucagon receptors. This multi-target mechanism is designed to enhance weight reduction while improving glucose regulation and broader cardiometabolic health. In TRIUMPH-3, retatrutide also produced meaningful improvements in several cardiovascular risk factors, including reductions in triglycerides, non-HDL cholesterol, systolic blood pressure, waist circumference, and high-sensitivity C-reactive protein (hsCRP), an important marker of systemic inflammation. Although the study was not powered to demonstrate cardiovascular superiority, the observed trends support continued investigation of retatrutide across broader cardiometabolic indications. The therapy’s safety profile remained generally consistent with the known gastrointestinal effects associated with incretin-based medicines, with most adverse events reported as mild to moderate and manageable during treatment.
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Lilly Advances Global Regulatory Plans for Retatrutide
The positive findings from TRIUMPH-2 and TRIUMPH-3 complete five successful Phase 3 studies evaluating retatrutide across obesity-related conditions, providing Lilly with the comprehensive clinical evidence required for global regulatory submissions. Beyond obesity, the company is investigating the therapy for knee osteoarthritis pain, obstructive sleep apnea, cardiovascular and renal outcomes, metabolic dysfunction-associated steatotic liver disease, and other cardiometabolic disorders. Lilly confirmed it is finalizing the required Chemistry, Manufacturing, and Controls (CMC) documentation before submitting its planned BLA to the FDA in early 2027. As obesity continues to affect millions worldwide and remains closely associated with diabetes, cardiovascular disease, and other chronic illnesses, retatrutide has the potential to become an important new therapeutic option that expands treatment choices while advancing the next generation of metabolic disease management through innovative triple-receptor biology.
Source: Eli Lilly press release
