Innovent announces positive topline results of the phase 3 GLORY-2 trial of mazdutide 9 mg, showing nearly 20% weight reduction in people with obesity and T2D –
Follows October 2025 announcement of positive topline results for the phase 3 DREAMS-3 trial of mazdutide showing superior A1c reduction and weight loss compared to Novo Nordisk’s Ozempic
Shanghai-based Innovent Biologics announced today positive topline results from the phase 3 GLORY-2 trial (n=462) evaluating mazdutide 9 mg, a dual GLP-1/glucagon RA, in Chinese adults with obesity. Mazdutide received approval from China’s NMPA in September 2025 for glycemic management in adults with T2D. The trial met all primary endpoints and key secondary endpoints: at Week 60, the mazdutide group achieved 19% mean weight loss versus 3% in placebo, with 44% achieving ≥20% body weight loss versus 3% in placebo. Participants without diabetes achieved 20% weight loss versus 3% in placebo, with 49% achieving ≥20% body weight loss versus 3% in placebo. Based on these results, Innovent plans to submit a new drug application (NDA) for mazdutide 9 mg to China’s NMPA in the near term.
Study design and baseline characteristics
GLORY-2 (n=462) was a phase 3 60-week double blind trial of Chinese adults with obesity and T2D who were randomized to receive mazdutide 9 mg or placebo in a 2:1 ratio. The primary endpoint was percent change in bodyweight from baseline to Week 60, and secondary endpoints included waist circumference, systolic blood pressure, triglycerides, non-HDL cholesterol, LDL cholesterol, and serum uric acid levels. Participants had a mean BMI of 34 kg/m², baseline weight of 94 kg (207 lbs), and 16% of participants had T2D. As we learned at ObesityWeek 2025, a number of countries in East Asia have lower BMI cutoffs for obesity compared to many western nations. In China, a BMI ≥28 kg/m2 is classified as obesity, while a BMI of ≥25 kg/m2 qualifies as obesity in Japan and South Korea.
Results: Mazdutide 9 mg demonstrated a 19% weight reduction in people with obesity and T2D
The trial met its primary endpoint, with the treated group achieving a mean body weight reduction of 19% versus 3% in the placebo group. Nearly half of participants in the mazdutide group achieved ≥20% body weight loss versus just 3% in the placebo group. Key secondary endpoints showed that participants without T2D in the mazdutide group achieved a mean weight reduction of 20% versus 3% in the placebo group, with 49% achieving a weight reduction ≥20% versus 3% in placebo.
Mazdutide also improved all key cardiometabolic endpoints, including waist circumference, systolic blood pressure, triglycerides, non-HDL-C, LDL-C, and serum uric acid levels. In a liver fat MRI-PDFF subset without diabetes and with baseline liver fat ≥10%, liver fat was also reduced by 72% versus a 5% increase in the placebo group. As we learned at EASL 2025, the phase 2 trial (LY3305677) evaluating mazdutide’s efficacy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) has completed.
Although CGM metrics were not collected in the GLORY-2 trial, we would have been very interested to see mazdutide’s effect on TIR for patients with T2D.
Safety and outlook: Mazdutide demonstrates positive safety and may be positioned as an alternative to metabolic surgery
Mazdutide 9 mg demonstrated a favorable safety profile with mostly mild-to-moderate transient GI events. Discontinuation due to adverse events was 3% for mazdutide versus zero instances in placebo, and no new safety signals were identified.
Notably, Professor Linong Ji (Peking University, China), principal investigator of the trial, views mazdutide 9 mg dose as a potential alternative to metabolic surgery for patients with BMI >32.5 kg/m² who often carry greater cardiometabolic risk.
Close Concerns’ Questions
- Might full results include a breakdown of weight reduction in people with T2D?
- Given the relatively high 9 mg dose of mazdutide, will full results provide more detail on discontinuation rates and tolerability?
- Given the relatively low discontinuation rate for the 9 mg dose, might this motivate investigation of higher doses of mazdutide?
- Does Innovent plan to expand mazdutide development beyond China to assess efficacy and safety in more diverse populations?
--by Kayla Mathieu, Nour Khachemoune, Monica Oxenreiter, and Kelly Close