A Study of HS-20094 in Patients With T2DM

Launched by JIANGSU HANSOH PHARMACEUTICAL CO., LTD. · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new medication called HS-20094 for adults with type 2 diabetes (T2D) who are not achieving good blood sugar control through diet, exercise, or a stable dose of metformin. The study will last for 32 weeks and will involve participants receiving either HS-20094 in different doses, a placebo (which looks like the medication but has no active ingredients), or another diabetes medication called dulaglutide. Researchers will primarily look at how much participants' blood sugar levels (measured by HbA1c) change during the trial.

To participate, individuals must be between 18 and 75 years old and have been diagnosed with type 2 diabetes for at least three months. They should have a specific range of blood sugar levels and a body mass index (BMI) of 22 or higher. However, people with certain conditions, like type 1 diabetes, recent serious heart issues, or significant recent weight changes, cannot join the trial. Participants can expect regular check-ins and assessments throughout the study to monitor their health and the effectiveness of the medication. This trial is currently recruiting participants, and it's a good opportunity for those seeking new treatment options for managing their diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female patients 18 to 75 years of age, inclusive
• • 2. Patients were diagnosed with T2DM for at least 3 months before screening.
• • 3. Have an HbA1c value at screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin (either immediate release or extended release, ≥1000mg/day and not more than the locally approved dose) for at least 2 months prior to screening
• • 4. Body mass index (BMI）≥ 22 kg/m2.
• Exclusion Criteria:
• • 1. Type 1 diabetes, gestational diabetes, monogenic diabetes, secondary diabetes, or undetermined diabetes as assessed by the investigator
• • 2. Acute or chronic pancreatitis at any time before screening, or serum lipase/amylase above the upper limit of normal at screening
• • 3. A history of grade 3 hypoglycemia (hypoglycemia with a serious event of consciousness and/or physical alteration requiring assistance from another person for recovery) within 6 months before screening
• • 4. Occurrence of diabetic ketoacidosis, hyperosmolar coma, or lactic acidosis two or more times within 6 months prior to screening
• • 5. Occurrence of any of the following events within 6 months prior to screening: acute myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention (excluding diagnostic angiography), transient ischemic attack, cerebrovascular accident, decompensated congestive heart failure, or Class III or IV heart failure (NYHA classification)
• • 6. Significant weight change (weight gain or loss ≥5%) within 3 months prior to screening (as reported by the participant)