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Clinical Trials in China / NCT07139548
Starting soon Phase 3

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

NCT07139548 · tracked via the Priya Life Science China tracker
Sponsor
Guangdong Raynovent Biotech Co., Ltd
Phase
Phase 3
Started
2025-08-31
Last updated
2025-08-24

Condition(s) studied

T2DM

Investigational drug(s) / intervention(s)

RAY1225Semaglutide

RAY1225: Administered SC

Semaglutide: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Heibei

On this site

📄 Ozempic (semaglutide) drug profile →

More Guangdong Raynovent Biotech Co., Ltd trials in China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07139548 on ClinicalTrials.gov ↗ ← All trials in China