Eli Lilly files for approval of tirzepatide's 5th indication in China

On November 13, the CDE website listed as accepted a new marketing application for Eli Lilly's tirzepatide. The Insight database speculates the proposed indication is for reducing the risk of major adverse cardiovascular events (MACE) in adults with type 2 diabetes who are at increased cardiovascular risk.

Source: CDE Official Website

Tirzepatide, a dual GLP-1R/GIPR agonist, is approved in China for three indications: glycemic control in adults with type 2 diabetes, long-term weight management, and obstructive sleep apnea. A fourth application submitted in December 2024 is speculated by the Insight database to be for heart failure with preserved ejection fraction (HFpEF) with obesity.

In late July this year, Eli Lilly announced results from the Phase III SURPASS-CVOT trial, a head-to-head comparison of tirzepatide versus dulaglutide in adults with type 2 diabetes and atherosclerotic cardiovascular disease. The study enrolled more than 13,000 patients across 30 countries and regions over more than 4.5 years, making it the largest and longest-duration tirzepatide trial to date.

Results showed the trial met its primary endpoint, demonstrating that tirzepatide was non-inferior to dulaglutide for the risk of major adverse cardiovascular events (MACE-3), a composite of cardiovascular death, myocardial infarction, or stroke. Additionally, tirzepatide showed improvements in HbA1c, body weight, renal function, and all-cause death; these findings are descriptive, as they were not controlled for type I error due to multiplicity.

The safety and tolerability profiles of tirzepatide and dulaglutide were largely consistent with previous data. In the SURPASS-CVOT trial, the most common adverse events for both were mild to moderate gastrointestinal reactions. These events predominantly occurred during the dose-escalation phase and subsided over time. The rates of discontinuation due to adverse events were 13.3% in the tirzepatide group and 10.2% in the dulaglutide group.