Tests RAY1225 against placebo in adults with type 2 diabetes
Tests RAY1225 against a placebo in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone
Key facts
- Where
- Beijingcun, ChinaSee the site
- Phase
- Phase 3
Where in China
- Peking University People's HospitalBeijingcun, 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
- NCT07139535
- Record updated
- 24 August 2025
- Original description
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.Read full original descriptionShow less
A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone
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.
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: 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.