Eli Lilly and Innovent’s obesity drug mazdutide achieves positive Phase III results

Innovent has reported positive Phase III results for mazdutide, Eli Lilly’s next-generation obesity asset that Innovent is developing as part of a 2019 deal with the company where it secured the rights to the dual glucagon-like peptide-1 (GLP-1) glucagon receptor agonist.

Innovent, a China-based biotech company, is aiming to launch the therapy in the rapidly growing Chinese obesity market.

The company announced that its Phase III GLORY-1 trial met both of its primary endpoints.

These successful results position mazdutide to be a leading obesity therapeutic in the Chinese market and demonstrate the strength of the obesity assets developed by Eli Lilly, although this is an Innovent therapy.

Mazdutide demonstrated superiority to placebo in reducing body weight by week 32 and a significant proportion of patients achieved weight loss of 5% or more, announcing that weight loss efficacy further improved from weeks 32 to 48.

Furthermore, GLORY-1 was able to meet its secondary endpoints, which included the proportion of patients who experienced weight loss of 10%, as well as significant changes in weight circumference, systolic blood pressure, triglycerides, and low-density lipoproteins.

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By GlobalData

Mazdutide demonstrated superiority compared to placebo across all of the weight loss and cardiometabolic endpoints and did not present any new safety signals, with the drug’s safety similar to that reported in previous trials with favourable safety and tolerability for submission to Chinese regulators.

Additionally, Innovent has launched a second Phase III obesity study, GLORY-2, which is assessing a 9mg dose, as opposed to GLORY-1’s focus on 4mg and 6mg doses.

The 9mg dose was identified as being favourable from previous Phase II trial results released in early 2023.

The Chinese obesity market is incredibly lucrative, with an estimated patient population size of 160,000,000 individuals.

Since Eli Lilly completed its Phase III trial for tirzepatide (Mounjaro in the US for Type 2 diabetes and Zepbound for obesity) at the end of 2022, the competition for market share has intensified.

Novo Nordisk won approval for its GLP-1 semaglutide (Ozempic and for its oral form Rybelsus), although this was only for Type 2 diabetes, with key opinion leaders interviewed by GlobalData, a leading data and analytics company, reporting off-label prescribing of Ozempic for obesity.

With mazdutide’s robust clinical data around multiple cardiometabolic indicators, the therapy is poised to gain widespread adoption in the Chinese market.

The global obesity therapeutic market is undergoing a significant expansion, spearheaded by Eli Lilly and Novo Nordisk, with an increasing number of large pharmaceutical companies currently developing their own early-stage assets.

With the current success of Ozempic, novel therapies that are approved following Ozempic’s launch are likely to have increased adoption from physicians across all major markets.

GlobalData forecasts that Innovent, as a Chinese biotech, is well-positioned to succeed in that market given the regulatory and logistical challenges for international pharmaceutical companies looking to enter the Chinese market.

Innovent will develop therapeutics for the cardiometabolic space in the Chinese market.

Although Innovent is likely to have initial success and gain a sizeable market share, there are strong contenders for competition in the form of Novo Nordisk’s well-established GLP-1 therapy, Ozempic, which is approved in China for Type 2 diabetes and used off-label for obesity, and Innovent may struggle to gain the majority market share.