Status:
NOT_YET_RECRUITING
A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Lead Sponsor:
Guangdong Raynovent Biotech Co., Ltd
Conditions:
T2DM
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.
Eligibility Criteria
Inclusion
- Have been diagnosed with type 2 diabetes mellitus (T2DM)
- 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.
- Have a body mass index (BMI) ≥20 kilograms per meter squared (kg/m²) at screening
- Be of stable weight (±5%) for at least 12 weeks before screening
Exclusion
- Have type 1 diabetes mellitus
- 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;
- History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;
- 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 ;
- History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;
- 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.);
- 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.).
Key Trial Info
Start Date :
August 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT07139535
Start Date
August 31 2025
End Date
December 31 2026
Last Update
August 24 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijingcun, Hebei, China