Compares RAY1225 with semaglutide in adults with type 2 diabetes
Tests RAY1225 against semaglutide, added to oral medicines, in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Peking University People's HospitalBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Guangdong Raynovent Biotech Co., Ltd
- Trial code
- NCT07139548
- Record updated
- 24 August 2025
- Original description
The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.Read full original descriptionShow less
A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes
The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.
Inclusion: Have been diagnosed with type 2 diabetes mellitus (T2DM); Have HbA1c between ≥7.0% and ≤11.5%; 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: History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization; 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.); Have type 1 diabetes mellitus; 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.); 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 ; 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.