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 HbA_1c𒆙, fasting blood gluc🐟ose 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:  Depar🌳tment of Endocrinology, Peking University First Hospital, Beijing, China, Junqing Zhang

First author: Departmen⛦t of Endocrinology, Peking Uni🧔versity 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 T_max was between 16 h-24 h. The geometric mean of T_1/2 was estimated to be between 144 h-162 h. Exposure (C_max and AUC) increased along with the dose within the range of 5–15 mg. OGTT Glucose AUC_0-2h 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 HbA_1c 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 semagl🎃utide 1.0 mg (p=0.0024).

Conclusion:

In patients with T2DM, HS-20094 was generally safe and showed meaningful HbA_1c, fasting blood glucose and boꦇdy weig🍨ht reductions.