<>
Eli Lilly plans to file for global regulatory approval of its next-generation obesity treatment, retatrutide, in the first quarter of 2027 after the weekly injection succeeded in two additional late-stage Phase 3 clinical trials, according to a statement released by the pharmaceutical company to CNBC. The company stated it needs additional time to gather and verify the manufacturing and quality-control data required by regulators before submitting its application.
Phase 3 Trial Results and Weight Loss Efficacy
In two separate Phase 3 trials evaluating adults with obesity alongside major health complications, retatrutide delivered significant weight reductions and improvements in blood sugar control, according to CNBC. Kenneth Custer, president of Lilly Cardiometabolic Health, stated in a release that the company believes it possesses the necessary data to seek global approvals for obesity, knee osteoarthritis pain, and obstructive sleep apnea.
In a trial involving adults with obesity and Type 2 diabetes, patients taking the drug lost up to an average of 20.8% of their body weight, equivalent to nearly 50 pounds, over an 80-week period. In a second trial focusing on adults with severe obesity and established cardiovascular disease—with or without diabetes—participants on the treatment lost up to an average of 22.6% of their weight, or 55.8 pounds, at 80 weeks, alongside meaningful reductions in certain cardiovascular risk factors.
Side Effects and Mechanisms of the Triple G Drug
The safety profile observed in the latest trials remained consistent with previous studies on the treatment, with the most frequent side effects including diarrhea, nausea, and constipation, according to CNBC. These gastrointestinal events align with the broader GLP-1 class of medications.
Often dubbed the “triple G” drug, retatrutide targets three distinct hormone receptors—GLP-1, GIP, and glucagon—rather than focusing on just one or two hormones like existing therapies. This multi-hormone targeting mechanism produces more potent effects on appetite and food satisfaction than treatments such as Eli Lilly’s tirzepatide (the active ingredient in Zepbound, which mimics GLP-1 and GIP) or Novo Nordisk’s semaglutide (the active ingredient in Wegovy, which mimics only GLP-1).
Market Positioning and Future Outlook
With positive results now recorded across five late-stage trials, Eli Lilly is positioning retatrutide as the upcoming pillar of its obesity portfolio, following its Zepbound injection and newly launched pill, Foundayo, according to CNBC. TD Cowen analysts estimated in a January note that retatrutide could generate sales reaching $3.8 billion by 2030.
The drug plays a critical role in the manufacturer’s strategy to defend and maintain its market share majority against rival Novo Nordisk in the rapidly expanding market for weight loss and diabetes medications, a segment some analysts estimate could reach approximately $100 billion by the 2030s.
Keep reading