2021-12-23
First participant dosed in the first-in-human study of a novel dual GLP-1/GIP receptor agonist
December 23, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced that the first participant has been dosed in a First-In-Human (FIH) Phase 1 study to evaluate the safety and tolerability of a novel dual GLP-1/GIP receptor agonist, subcutaneously administered as single or multiple doses in healthy subjects.
About the Novel Dual GLP-1/GIP Receptor Agonist
Hengrui's novel dual GLP-1/GIP receptor agonist showed stronger agonist action at the human GLP-1 receptor and comparable pharmacokinetic (PK) profiles versus positive controls (including one with dual agonist activities) in preclinical studies. It demonstrated promising therapeutic effects in animal models of diabetes, non-alcoholic steatohepatitis (NASH), and obesity, with a favorable efficacy profile in lowering HbA1c, NAFLD Activity Score (NAS) and body weight as compared with positive controls.
The novel dual GLP-1/GIP receptor agonist is being investigated in a Phase 1 study in healthy subjects in China. In addition, a Phase 1 study in patients with type 2 diabetes in China and a PK bridging study in Australia are under planning.
About the Study
This study is a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose FIH Phase 1 study of subcutaneously administered dual GLP-1/GIP receptor agonist in healthy subjects, which is planned to enroll 100 participants.
The primary endpoint is the number of treatment emergent adverse events. The secondary endpoints include PK, pharmacodynamics and immunogenicity of this drug in healthy subjects.
About Diabetes
Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces.1 537 million adults are living with diabetes worldwide.2 Type 2 diabetes accounts for approximately 95% of all diagnosed cases of diabetes, and it is largely the result of excess body weight and physical inactivity.1
In 2019, diabetes was the direct cause of 1.5 million deaths and 48% of all deaths due to diabetes occurred before the age of 70.1 Although multiple treatment options are on the market, there still remains huge unmet medical needs in improving the life quality of patients living with diabetes.
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 24th among the top 1,000 global pharma companies in 2021.3 Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.
1. https://www.who.int/news-room/fact-sheets/detail/diabetes
2. International Diabetes Federation. IDF Diabetes Atlas, 10th edition. Available at: https://diabetesatlas.org/atlas/tenth-edition/
3. https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf.
BD Contact
Email: bd@hengrui.com
Phone: +86-21-61053532