A Phase 3 Study of HS-20094 in Patients With T2DM Inadequately Controlled With Diet and Exercise Alone

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. ·

Keywords

ClinConnect Summary

This is a Phase 3 clinical trial testing whether weekly injections of a medicine called HS-20094 can improve blood sugar control in adults with type 2 diabetes who are not adequately controlled with diet and exercise alone. The study compares HS-20094 to a placebo (inactive shot) in a double-blind design, meaning neither participants nor most study staff know who receives the real medicine. The main goal is to see how much the average blood sugar, shown by HbA1c, changes after about 44 weeks of treatment, with a follow-up to 52 weeks. Researchers will also look at other outcomes, such as the number of people who reach target HbA1c levels, changes in fasting blood sugar, body weight, and how many people lose at least 5% or 10% of their body weight. Safety will be monitored, including any side effects, up to 52 weeks plus an extra follow-up period.

Who can join: adults aged 18 and older with type 2 diabetes for at least 3 months, who have been managing their condition with diet and exercise alone for at least 3 months, and who have an HbA1c between 7.5% and 10.5% at screening. Exclusions include uncontrolled high blood pressure, other forms of diabetes, certain blood disorders or thyroid problems, recent major illness or surgery, or recent participation in another trial. About 204 people will be enrolled at centers in China (Beijing). If you join, you would receive weekly injections of HS-20094 or a matching placebo, in addition to your usual care, and you would be regularly checked for safety and any side effects. The study is expected to start around late September 2025 and finish around May 2027.

Gender

ALL

Eligibility criteria