A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

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

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called RAY1225 to see if it can help people with type 2 diabetes better control their blood sugar when diet and exercise alone are not enough. The study will compare RAY1225 to a placebo (a pill with no active medicine) to check how well it works and how safe it is for participants.

People who might be eligible for this study are adults aged 18 to 74 who have type 2 diabetes and either have only managed their condition through diet and exercise or have taken certain oral diabetes medicines but stopped at least 12 weeks before joining. Participants should have a stable body weight and a body mass index (BMI) of 20 or higher. The study does not include people with type 1 diabetes, serious diabetes-related eye problems, recent severe low blood sugar events, or certain other health issues that could affect blood sugar control. If you join, you can expect to take either the study drug or a placebo and be monitored regularly to see how your blood sugar responds and to check for any side effects. This study is not yet recruiting, so it will start enrolling participants in the near future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have been diagnosed with type 2 diabetes mellitus (T2DM)
• • 2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.
• • 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.).