Overview
- Lilly announced Thursday that two new 80-week Phase 3 trials showed average weight loss of 20.8% in adults with obesity and type 2 diabetes and 22.6% in adults with severe obesity and established cardiovascular disease.
- The company said it will file a biologics license application in the first quarter of 2027 after completing manufacturing and quality-control verification required for a U.S. submission.
- Lilly reported a developing cardiovascular safety signal showing a 12% higher risk for the three most severe events—heart attack, stroke, and death—when compared with placebo and said regulators will need to evaluate that finding.
- Common side effects were gastrointestinal, including nausea, diarrhea, and constipation, and the diabetes trial also showed a 1.6% average A1C reduction at the highest dose.
- Retatrutide targets three hormones (GLP-1, GIP, and glucagon) and could expand Lilly's cardiometabolic portfolio and reach new indications, a development that may change treatment options and payer decisions if regulators clear safety and manufacturing issues.