Innogen announces Phase III efsubaglutide alfa results at the 83rd ADA Scientific Sessions
Innogen seeks to provide innovative, accessible, affordable and high-quality medicines for metabolic diseases. The company describes efsubaglutide alfa as China’s first domestically originated humanised long-acting GLP-1 receptor agonist, with development programs in type 2 diabetes mellitus (T2DM), obesity and NASH. Assessment of the primary efficacy endpoints during the 24-week double-blind treatment periods of two Phase III T2DM studies had been completed. The findings were accepted for presentation at the 83rd ADA Scientific Sessions and disclosed on 25 June.
Efficacy and safety of efsubaglutide alfa monotherapy in type 2 diabetes¹
The randomised, double-blind, placebo-controlled Phase III trial NCT04994288 assessed weekly efsubaglutide alfa or placebo in 297 people with newly diagnosed T2DM inadequately controlled by diet and exercise. At week 24, HbA1c had fallen by 1.73 and 2.15 percentage points from baseline in the 1 mg and 3 mg weekly groups, respectively, with statistically and clinically significant effects (P<0.001). Efsubaglutide alfa also improved glucose tolerance and increased meal-stimulated insulin and C-peptide secretion, indicating improved β-cell function. The most common adverse reactions were gastrointestinal and were mild or moderate. The study reported improved glucose and metabolic control with a favourable safety profile.
Efficacy and safety of efsubaglutide alfa with metformin in type 2 diabetes²
The randomised, double-blind, placebo-controlled Phase III trial NCT04998032 assessed weekly efsubaglutide alfa or placebo added to metformin in 340 people with inadequately controlled T2DM. At week 24, HbA1c had fallen by 1.81 percentage points from baseline with efsubaglutide alfa 3 mg weekly, a statistically and clinically significant effect (P<0.001). Glucose tolerance and meal-stimulated insulin and C-peptide secretion also improved, indicating improved β-cell function. The most common adverse reactions were gastrointestinal, mainly mild or moderate. The study reported that 3 mg supaglutide improved glucose and metabolic control in people inadequately controlled on metformin, with a favourable safety profile.
Diabetes is a chronic metabolic disease with a major impact on health. The article reports more than 140 million people with diabetes in China and a substantial economic burden. It identifies considerable clinical need for a domestically produced human long-acting GLP-1RA and describes the efsubaglutide alfa T2DM findings as supporting clinical value, safety and an additional treatment option.
References: 1. Diabetes. 2023;72(Supplement_1):757-P. 2. Diabetes. 2023;72(Supplement_1):778-P.
Study terminology in the original English version
The company’s original English version explicitly compares HbA1c reductions in both trials with placebo. It describes other findings as improved glucose excursions, increased meal-stimulated insulin and C-peptide secretion, and enhanced β-cell function; the Chinese source uses glucose tolerance in the corresponding passages. The English version calls the gastrointestinal events treatment-emergent adverse events (TEAEs), generally mild or moderate. That term alone does not attribute every event to the medicine. It also gives the historical Chinese diabetes population more precisely as over 141 million. Both versions cite the 2023 ADA abstracts 757-P and 778-P.