ADA24: Lilly and Innovent's obesity drug shows strong results in China

China's Innovent Biologics has revealed new Phase III data that strengthens the competitive edge of its obesity drug, mazdutide (IBI362). The findings were presented at the American Diabetes Association (ADA) scientific sessions and align with the recent Chinese regulatory approval of Novo Nordisk's weight loss drug, Wegovy (semaglutide).

The GLORY-1 trial involved 610 Chinese participants who were either overweight or obese. The primary endpoint was the change in weight from baseline to week 32. Results showed that mazdutide, a dual GLP-1/glucagon agonist developed in partnership with Eli Lilly, achieved placebo-adjusted weight loss of 11% at the 4mg dose and over 13% at the 6mg dose. By week 48, the 6mg dose resulted in a 14.3% placebo-adjusted weight loss.

Bloomberg Intelligence analysts Michael Shah and Leslie Yang compared mazdutide's efficacy to Eli Lilly's Zepbound (tirzepatide) for weight loss, projecting potential sales in China to reach $1.3 billion by 2030. Morgan Stanley analysts were also optimistic, noting that the ADA data reinforces mazdutide as a strong contender in China's GLP-1 market. Additionally, a 9mg dose of mazdutide is currently in Phase III trials for weight loss, with results expected in 2025.

Wegovy's patent in China is set to expire in 2026, prompting domestic pharmaceutical companies to prepare generic versions. Concurrently, Eli Lilly's Mounjaro (tirzepatide) has been approved as a diabetes treatment in China, which may lead to increased off-label prescriptions for weight loss.

In an exploratory analysis of the GLORY-1 study, mazdutide also showed an 80.2% reduction in liver fat content among participants with baseline liver fat content of 10% or higher. Principal investigator Linong Ji emphasized the drug's potential impact on metabolic dysfunction-associated fatty liver disease (MAFLD), noting that the reduction in liver fat content was greater than that observed with GLP-1 receptor mono-agonists and other dual-target agonists in previous studies.

However, Morgan Stanley highlighted that Innovent has acknowledged uncertainties regarding the benefits of the GLP-1/glucagon receptor mechanism in improving fibrosis. The company noted that discussions with regulators on development plans—including timing, patient size, and diagnostic methods—are still ongoing.

No new safety issues emerged in the trial, and mazdutide's safety profile was consistent with previous studies. The most common side effects reported were mild-to-moderate gastrointestinal events such as nausea, diarrhea, and vomiting. Serious adverse events were rare and comparable to placebo. Innovent also reported that mean changes in heart rate were no more than 5 beats per minute during the 48-week treatment period for both mazdutide dose groups. Morgan Stanley analysts welcomed this finding, contrasting it with historical concerns of double-digit heart rate increases.

In May, Innovent announced that mazdutide showed superiority over Lilly's GLP-1 agonist Trulicity (dulaglutide) in glycemic control and multiple cardiometabolic outcomes for Chinese patients with type 2 diabetes, based on Phase III results from the DREAMS-2 study.