Eli Lilly announced on Thursday that two additional Phase 3 clinical trials for its next-generation obesity drug have succeeded, with the company planning to submit a marketing application for the drug in the first quarter of 2027.
The pharmaceutical giant had previously stated it could file for approval of this once-weekly injectable, retatrutide, as early as this year. The drug's mechanism of action differs from existing injectables and oral medications, and its efficacy appears more pronounced. In a statement, Eli Lilly said it needs more time to collect and verify the manufacturing and quality control data required by regulators before it can submit the drug for approval.
Results from two independent Phase 3 clinical trials showed that retatrutide significantly reduced body weight and improved a key blood sugar indicator in adult patients who are obese and also have two major complications: type 2 diabetes and confirmed cardiovascular disease.
Kenneth Kaste, President of Eli Lilly's Cardiometabolic Health division, stated in the announcement that based on the available data, the company has sufficient evidence to submit applications globally seeking approval for retatrutide to treat obesity, knee osteoarthritis pain, and obstructive sleep apnea.
In one trial, subjects who were obese and had diabetes took the drug for 80 consecutive weeks, achieving an average maximum weight loss of 20.8%, or approximately 50 pounds. This patient population is typically difficult to achieve weight loss in.
Another trial enrolled severely obese adults with confirmed cardiovascular disease (with or without diabetes). After 80 weeks of treatment, subjects achieved an average maximum weight loss of 22.6%, or about 55.8 pounds. Eli Lilly added that retatrutide significantly reduced multiple cardiovascular risk indicators in patients.
The adverse drug reactions observed in the two trials were consistent with results from prior related studies. The most common side effects included diarrhea, nausea, and constipation, which are common across the entire class of GLP-1 drugs.
Retatrutide has now achieved positive results in five late-stage clinical trials. Following the injectable Zepbound and the recently launched oral drug Foundayo, Eli Lilly is positioning retatrutide as another core product in its obesity pipeline. In a January research report, analysts at Tudor Pickering Holt & Co. predicted that retatrutide's sales could reach $3.8 billion by 2030.
The weight loss and diabetes drug market continues to expand rapidly, and retatrutide is crucial for Eli Lilly as it serves as a key strategy to maintain its market share advantage over Novo Nordisk. Some analysts predict the market could reach approximately $100 billion by the 2030s.
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