EASD2024 | HANSOH PHARMA RELEASED THE PHASE II CLINICAL STUDY DATA OF THE NOVEL DUAL GIP AND GLP-1 RECEPTOR AGONIST
The 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) was held in Madrid, Spain, from 9 to 13 September 2024. Hansoh Pharma's HS-20094 (a novel dual GIP and GLP-1 Receptor Agonist) Phase II clinical Study Data were presented in the form of an short oral discussion.
The EASD Annual Meeting is one of the largest diabetes conferences in the world, attracting thousands of delegates each year. The scientific programme includes hundreds of talks, presentations and discussions on the latest results from basic and clinical diabetes research.
HS-20094, independently developed by Hansoh Pharma, is a novel dual GIP and GLP-1 Receptor Agonist. It promotes insulin secretion, slows gastric emptying, and suppresses appetite to reduce food intake, thereby exerting biological effects such as glycemic control, weight loss, and metabolic improvement. The drug is administered subcutaneously once a week.
The recently published Phase II study results of HS-20094 demonstrate that in patients with T2DM, HS-20094 was generally safe and showed meaningful HbA1c, fasting blood glucose and body weight reductions.
Study Profile
Efficacy and safety of HS-20094 in patients with type 2 diabetes: a randomized, double-blind, placebo-controlled, phase 2 trial
Format: Short Oral Discussion
Presentation#: 732
Corresponding author: Department of Endocrinology, Peking University First Hospital, Beijing, China, Junqing Zhang
First author: Department of Endocrinology, Peking University First Hospital, Beijing, China, Lin Liu
Date: September 12, 2024,14:00 (CEST)
Introduction and Objective
HS-20094 is a novel dual GIP and GLP-1 receptor agonist. A 4-week PoC study was conducted to assess the preliminary efficacy and safety of HS-20094 compared with placebo or semaglutide in patients with poorly controlled type 2 diabetes (T2DM).
Methods
This was a randomized, double-blind, placebo-controlled trial. Patients with T2DM poorly controlled with diet and exercise alone or with stable metformin (HbA1c ≥7.0 to ≤10.0%) were randomly (4:1:1) assigned within each cohort to receive HS-20094 (5mg, 10mg or 15mg), semaglutide (1.0mg), or placebo subcutaneously once-weekly. The primary endpoint was the safety of HS-20094.
Results
Totally, 54 subjects received at least one dose of HS-20094, semaglutide or placebo.
Most (98%) adverse events (AEs) reported were mild or moderate. The most common AEs were gastrointestinal AEs, with no apparent dose-dependency observed. No drug-related serious AEs, no AEs leading to discontinuation, no death, and no severe hypoglycemia events were reported. After 4 weeks of titrated administration, the median Tmax was between 16 h-24 h. The geometric mean of T1/2 was estimated to be between 144 h-162 h. Exposure (Cmax and AUC) increased along with the dose within the range of 5–15 mg. OGTT Glucose AUC0-2h on Day 23 was significantly decreased with HS-20094 compared with placebo, in a dose-dependent manner. HS-20094 15 mg showed statistically greater reduction than semaglutide 1.0 mg. In OGTT, both blood glucose level at 0 min and 120 min were decreased on Day 23 compared with placebo. A significant decrease in HbA1c was observed on Day 29 in all HS-20094 dose groups and semaglutide group compared to placebo. Mean body weight reduced in a dose-dependent manner in the HS-20094 dose groups, with up to approximate 4.8 % weight loss in the 15 mg group on day 29. The change from baseline was statistically greater with HS-20094 15 mg compared with semaglutide 1.0 mg (p=0.0024).
Conclusion
In patients with T2DM, HS-20094 was generally safe and showed meaningful HbA1c, fasting blood glucose and body weight reductions.
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, anti-infectives, central nervous system (CNS), metabolism and immunology. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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