A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes

Launched by GUANGDONG RAYNOVENT BIOTECH CO., LTD · Aug 17, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new medicine called RAY1225 works compared to an existing medicine called semaglutide in people with type 2 diabetes. Both medicines would be added to the oral diabetes drugs that participants are already taking. The main goal is to see which medicine better helps control blood sugar levels.

To join this study, participants need to have type 2 diabetes with blood sugar levels that are a bit high (measured by a test called HbA1c between 7.0% and 11.5%). They should also have a stable body weight and a body mass index (BMI) of 20 or higher. The study is open to adults aged 18 to 74, and both men and women can participate. People with type 1 diabetes, serious diabetes complications, recent severe low blood sugar episodes, or other health issues that affect blood sugar won’t be eligible. Participants can expect to take either RAY1225 or semaglutide along with their usual diabetes pills, and the study will closely monitor their blood sugar and overall health. This trial is not recruiting yet but aims to find better treatment options for managing type 2 diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have been diagnosed with type 2 diabetes mellitus (T2DM)
• • 2. Have HbA1c between ≥7.0% and ≤11.5%
• • 3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
• • 4. Be of stable weight (±5%) for at least 12 weeks before screening
• Exclusion Criteria:
• • 1. Have type 1 diabetes mellitus
• • 2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;
• • 3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
• • 4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \<3.0 mmol/L) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;
• • 5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
• • 6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation/loss ≥400 mL within 12 weeks prior to screening, or blood donation/loss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);
• • 7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).