Innovent Biologics Starts Phase 3 Trial of Mazdutide for Obesity and Fatty Liver Disease

Innovent Biologics, Inc. has reached an important milestone in its ongoing quest to provide effective treatment for individuals suffering from obesity and metabolic dysfunction-related fatty liver disease (MAFLD) in China. The company successfully completed the first participant dosing in GLORY-3, a significant Phase 3 clinical study evaluating mazdutide, a dual glucagon (GCG) and glucagon-like peptide 1 receptor (GLP-1) receptor agonist. This progression is especially notable as it marks an essential step in understanding the potential benefits of Mazdutide in managing conditions that plague a vast number of adults in the region.

Study Overview

The GLORY-3 study is a multicenter, randomized, open-label trial that aims to compare the efficacy and safety of Mazdutide against Semaglutide in adults with overweight or obesity alongside metabolic dysfunction-associated fatty liver disease (MAFLD). Targeting approximately 470 participants with a body mass index (BMI) of 27 kg/m² or more, this study seeks to gather essential data on its effectiveness in reducing liver fat content and body weight over 48 weeks. Participants will be administered either Mazdutide at 9 mg or Semaglutide at 2.4 mg.

One of the main objectives of GLORY-3 is to measure the change in liver fat content (LFC) using magnetic resonance proton density fat fraction (MRI-PDFF) as well as the percentage change in body weight from baseline at week 48. These metrics are vital in determining the overall impact of the treatment on both liver health and weight loss, imperative factors in managing obesity and its related complications.

Previous Positive Outcomes

Earlier studies, notably a Phase 2 trial involving Chinese adults with obesity, have already demonstrated promising results for Mazdutide. Participants in that study who received Mazdutide experienced an impressive average weight reduction of 18.6% (or approximately 17.8 kg) compared to the placebo group after 48 weeks. Additionally, a substantial segment of the participants achieved significant weight loss, with 51.2% losing 15% of their baseline weight and 34.9% recording a loss of 20% or more. Participants presenting with a baseline LFC of 5% or higher also observed a remarkable 73.3% reduction in liver fat within just 24 weeks of treatment, further cementing Mazdutide’s potential efficacy.

Professor Lixin Guo from Peking University People's Hospital, who leads this research, emphasized that MAFLD has now become the most prevalent chronic liver condition globally. It has surpassed viral hepatitis in chronic liver disease cases in China due to rising obesity rates. The need for effective treatments is more pressing than ever, and GLORY-3 positions Mazdutide as a promising option that could bridge the gap in available therapies.

Bridging Treatment Gaps

Dr. Lei Qian, Innovent’s Senior Vice President of Clinical Development, articulated the unique attributes of Mazdutide that set it apart from conventional therapies. As a dual GCG and GLP-1 receptor agonist, Mazdutide offers multiple metabolic benefits including enhanced lipolysis, improved fatty acid oxidation, and a comprehensive approach to weight loss and liver fat reduction. This dual-action mechanism is characterized by the stimulation of the glucagon receptor, which may surpass the benefits provided solely by GLP-1 receptor agonists, such as Semaglutide.

The higher prevalence of overweight and obesity in China necessitates innovative and effective treatments that go beyond lifestyle modifications. Not only does obesity come with an array of associated health risks, but it profoundly impacts life expectancy and quality of life. Therefore, the pursuit of successful pharmacological interventions has garnered attention and hope among healthcare professionals focusing on metabolic health in China.

Conclusion

Mazdutide represents a significant advance in the ongoing battle against obesity and metabolic diseases, especially in regions where these conditions are prevalent. The comprehensive nature of the GLORY-3 study aims to validate its effectiveness and safety as a dual-action treatment option, potentially offering patients a new lifeline in managing their condition. For Innovent Biologics, this study signals a commitment to advancing healthcare solutions that have the power to transform lives and improve health outcomes in the face of rising rates of obesity and associated complications in China.