A Phase 3 Study of HS-20094 in Patients With T2DM

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. ·

Keywords

ClinConnect Summary

This Phase 3 study is testing HS-20094, a weekly injectable medicine, in adults with type 2 diabetes that isn’t well controlled on metformin (with or without an SGLT2 inhibitor). Participants are randomly assigned to receive either two different doses of HS-20094 or dulaglutide (an existing weekly diabetes medicine) to see which helps lower blood sugar best over about 44 weeks (with follow-up data through 52 weeks). The main goal is to measure change in HbA1c, a blood test that shows average blood sugar over the last 2–3 months. Secondary goals include how many people reach target HbA1c levels (<7% or ≤6.5%), changes in fasting blood sugar and body weight, and how many lose 5% or 10% of their body weight, along with the overall safety and any side effects.

Eligibility is for adults 18 and older with type 2 diabetes who are on a stable metformin dose (at least 1500 mg daily) or metformin plus an SGLT2 inhibitor, and have HbA1c between 7.5% and 11% with BMI of 23 or higher. Key exclusions include uncontrolled high blood pressure and certain other medical conditions. The study is being conducted in China at a couple of hospitals and is sponsored by Jiangsu Hansoh Pharmaceutical. It is not currently recruiting, with an estimated start around September 30, 2025 and a planned completion around May 30, 2027. Participants would receive weekly injections and be monitored for effectiveness and safety.

Gender

ALL

Eligibility criteria