Original report
The first participant was enrolled on 25 August in an Australian randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy, safety and pharmacokinetics of Efsubaglutide Alfa Injection in people with overweight or obesity. The trial will explore dosing every two or four weeks, based on the drug’s longer half-life of 256–287 hours in people with obesity. It will assess percentage change in body weight from baseline after 22 weeks of subcutaneous treatment. The study plans to recruit 200 participants at five Australian research centers.
Age range of the population estimate
The cited Lancet analysis covers adults aged 25 and older. Its 2021 estimates of approximately 2.11 billion people and 45.1% apply to that age group, not to the entire world population.
Overweight and obesity are chronic metabolic diseases caused by multiple factors and are important risk factors for chronic diseases such as diabetes, cardiovascular and cerebrovascular diseases, metabolic associated fatty liver disease (MAFLD), sleep apnea syndrome, and cancer. A study on the global burden of overweight and obesity published in The Lancet in March 2025 shows that the rates of overweight and obesity have increased globally and regionally from 1990 to 2021. The total number of overweight or obese adults worldwide has exceeded 2.1 billion, accounting for 45.1% of the global population, including approximately 1 billion men and 1.1 billion women. Compared to 1990, the obesity rate among men has increased by 155.1% (from 5.8% to 14.8%), and among women by 104.9% (from 10.2% to 20.8%). Based on this epidemiological data, it is estimated that by 2050, more than 50% of the global adult population will be overweight, and the number of overweight and obese people worldwide will reach 3.8 billion, accounting for 60% of the global adult population【1】. Therefore, the scientific management of overweight and obesity, as well as drug treatment in addition to lifestyle and behavioral interventions, is particularly important.
Efsubaglutide Alfa is a long-acting humanized GLP-1 RA independently developed by Innogen. It is a fusion protein of human GLP-1 and human immunoglobulin IgG2-Fc segment, which has a high affinity for the GLP-1 receptor and can improve obesity by reducing food intake and promoting the browning of white fat【2】. The Efsubaglutide Alfa injection has the ability to avoid degradation by related hydrolases and filtration by the kidneys in the body, thus having strong efficacy and a long-lasting effect. The drug was approved by the National Medical Products Administration in January 2025 for the treatment of adult type 2 diabetes as a monotherapy or in combination with metformin. In addition to type 2 diabetes, Efsubaglutide Alfa is also undergoing clinical development for the indication of overweight/obesity. Besides the completed Phase IIa clinical study and ongoing Phase IIb/III clinical study in China, a weight loss study for overweight/obese populations in Australia is also underway, aiming to bring this long-acting, potentially once-every-two-weeks subcutaneous injection GLP-1 RA to patients worldwide as soon as possible.
In addition to type 2 diabetes and overweight/obesity, Innogen is also actively expanding the development of Efsubaglutide Alfa in other potential indications such as metabolic dysfunction-associated steatohepatitis (MASH), aiming to provide better treatment options for people living with these common chronic diseases as soon as possible.
Ng, Marie et al. Global, regional, and national prevalence of adult overweight and obesity, 1990–2021, with forecasts to 2050: a forecasting study for the Global Burden of Disease Study 2021. The Lancet. 2025;405(10481). https://doi.org/10.1016/S0140-6736(25)00355-1
Y. Wan, X. Bao, J. Huang, et al. Novel GLP-1 Analog Supaglutide Reduces HFD-Induced Obesity Associated with Increased Ucp-1 in White Adipose Tissue in Mice [J/OL]. Frontiers in physiology, 2017, 8: 294.