Innovent Biologics’ obesity drug has shown success in another pivotal trial, meeting the primary and all key secondary endpoints.
In the Phase III GLORY-2 trial (NCT06164873), Xinermei (mazdutide) 9mg led to a weight reduction of 18.55%, compared to 3.02% in the placebo group after 60 weeks of treatment.
In patients dosed with the Chinese biopharma’s drug, 44% achieved a weight reduction of 20% or more, versus 2.6% in the placebo group.
In patients with obesity but without type 2 diabetes, there was a mean weight reduction of 20.08% at week 60, compared to 2.81% in the placebo cohort, with 48.7% of patients achieving a weight reduction of 20% or more, meeting a key secondary endpoint.
Other key secondary endpoints, including other body weight endpoints, waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and serum uric acid levels, were also met.
The trial also evaluated liver fat content using magnetic resonance imaging-proton density fat fraction (MRI-PDFF) in patients with a liver fat content of at least 10%. In patients dosed with Xinermei 9mg, there was a 71.9% drop in liver fat content compared with a 5.1% increase in the placebo group.
The study investigated Xinermei 9mg, a dual glucagon (GCG)/glucagon-like peptide-1 receptor agonist (GLP-1RA), in 462 adults with obesity in China.
Professor Linong Ji, the leading principal investigator of the study, Peking University People’s Hospital, said: “China faces a high prevalence of obesity, with obese individuals bearing a significant burden of cardiometabolic diseases. Those with a BMI exceeding 32.5 kg/m² often experience an even greater cardiometabolic burden. This patient population requires special attention in clinical weight management and metabolic syndrome prevention.”
Based on the recent trial, Innovent plans to submit the new drug application (NDA) for 9mg Xinermei for weight management to the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA).
The drug has already been approved in China at 4mg and 6mg dosing in obesity, based on the GLORY-1 trial (NCT05607680), and type 2 diabetes, based on the DREAMS-1 (NCT05628311) and DREAMS-2 (NCT05606913) studies. The GLORY-2 trial data will set the company up for approval in the higher dose of Xinermei in obesity.
The company has two more Phase III trials, GLORY-3 (NCT06884293) and GLORY-OSA (NCT06931028), which are exploring the drug in obesity-linked metabolic–associated fatty liver disease and obstructive sleep apnoea, respectively.
GLP-1RAs continue to dominate obesity and type 2 diabetes arena
Innovent added Xinermei to its pipeline as part of an exclusive licence deal in place with Eli Lilly to develop and market the drug in China, which was signed in 2019.
Even without Eli Lilly marketing Xinermei, it is a huge powerhouse in the obesity space. The company’s subcutaneous GLP-1RA, Zepbound (tirzepatide) generated sales of $3.6bn in Q3 2025.
It is also currently awaiting a decision from the US Food and Drug Administration (FDA) on the approval of its oral GLP-1RA orforglipron, which has succeeded in Phase III trials in both obesity and type 2 diabetes.
Lilly’s main rival, Novo Nordisk, is also hoping for approval of its oral GLP-1RA Wegovy (semaglutide) after a successful Phase III trial. The drug is already approved in its subcutaneous form in obesity, with an oral version, Rybelsus, approved in type 2 diabetes.
GlobalData predicts that the obesity market will reach $206.5bn, up from $12.3bn across the 68 markets, with $981.3m of that expected from the Asia-Pacific (APAC) region.
GlobalData is the parent company of Clinical Trials Arena.
