The 2024 ADA Meeting was held in Orlando, USA, from June 21st to 24th, this year. 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 a poster + e-poster live Q&A at the conference.

The American Diabetes Association (ADA) Meeting is one of the largest and most prestigious diabetes academic conferences in the world, attracting over 10,000 participants from around the globe each year, including physicians, clinicians, nurses, and researchers. The conference provides attendees with opportunities to interact and exchange views with diabetes experts, as well as keep up with the latest advancements in diabetes research, treatment, and care.

Recent reports indicate that around 537 million adults worldwide (aged 20-79) had diabetes in 2021 (about 1 in 10 people), and it is estimated that this number may rise to 643 million by 2030 and to 783 million by 2045. During this period, the world population is projected to grow by 20%, while the number of diabetes patients is expected to increase by 46%^[1]. The prevalence of type 2 diabetes in China also shows an increasing trend year by year. The prevalence rate had climbed up to 11.2% during the period from 2015 to 2017, with type 2 diabetes accounting for over 90% of the total morbidity population^[2], demonstratin♔g a significant unmet clinical need.

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 HS-20094 exhibits excellent safety and tolerability profiles in type 2 diabetes patients, along with superior glucose-lowering and weight-loss effects.

Study Profile

Safety and Efficacy of HS-20094 in Patients with Type 2 Diabetes: A Randomized, Double-blind, Placebo-controlled, Phase 2 Study

Poster number：733-P

STUDY DESIGN• This was a randomized, double-blind, placebo-controlled, active referenced trial (NCT06118008).• In this phase 2 study, we further explored the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-20094 in patients with type 2 diabetes mellitus (T2DM).• were enrolled and randomized at 4：1：1 to double-blind HS-20094 (5 mg, 10 mg or 15 mg), placebo and open-label semaglutide (1.0 mg) once-weekly with rapid titration methods.• Administration: Injection was given subcutaneously once a week for 4 weeks.

RESULTS

Participants

A total of 54 participants received at least one dose, including 36, 9, and 9 in the HS-20094 group, semaglutide group, and placebo group, respectively.

Safety

•  HS-20094 was well-tolerated in patients with T2DM.Most (98%) adverse events (AEs) reported were mild or moderate. The most common AEs were gastrointestinal AEs,with no apparent dose-dependency observed (Table 1).One SAE unrelated to the study drug occurred in HS-20094 5mg group; No SAE occurred in HS-20094 10mg group, HS-20094 15mg group, placebo group and Semaglutide group during the study.• No drug-related serious AEs, no AEs leading to discontinuation,no death, and no severe hypoglycemia events were reported.

PK Profile

• After a 4-week period of titrated administration：The median T_max was between 16h and 24h.

• The geometric mean of t_1/2 was estimated to be between 142h and 168h.

•Exposure (C_max&🃏nb💮sp;and AUC) increased in an approximately dose-proportionally manner.

PD (Blood Glucose Lowering)

• OGTT Glucose AUC_0-2h on Day 23 was significantly decreased with HS-20094 compared with placebo, in a dose-dependent manner. On Day23, insulin AUC_0-2h and C-peptide AUC_0-2h were signif꧑icantly increased by all doses of HS-20094 treatment compared with placebo. HS-20094 15 mg showed statistically greater reduction than semaglꦓutide 1.0 mg .

• A significant decrease in HbA1c was observed on Day 29 in all HS-20094 dose groups and semaglutide group compared to placebo.

PD (Weight Loss)

• Mean body weight reduced in a dose-dependent manner in the HS-20094 dose groups, with up to 4.8% of weight loss in the 15 mg group.• The change from baseline was statistically greater with HS- 20094 15 mg compared with semaglutide 1.0 mg.

CONCLUSION

The above data showed that each dose of HS-20094 was significantly better than that of the placebo group in terms of glucose reduction and weight loss.More data for the comparison of HS-20094 and semaglutide will be published later.

At present, Hansoh Pharma has initiated and accelerated a further study of HS-20094 in patients with type 2 diabetes, and overweight/obesity in China. It is hoped that the drug will bring benefits to these patients.

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